Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear - Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear

Start Date10 Dec 2018

Sponsor / Collaborator

Medtronic Japan Co. Ltd.

NCT03647475 / CompletedNot Applicable

Onyx ONE Clear: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)

The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Start Date01 Oct 2018

Sponsor / Collaborator

Medtronic Vascular, Inc.

KCT0003082 / RecruitingPhase 4IIT

Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions.

Start Date30 Sep 2016

Sponsor / Collaborator-

100 Clinical Results associated with Zotarolimus

100 Translational Medicine associated with Zotarolimus

100 Patents (Medical) associated with Zotarolimus

754

Literatures (Medical) associated with Zotarolimus

01 Jan 2024·Cardiovascular revascularization medicine : including molecular interventions

Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging

Article

Author: Loussararian, Arthur ; Windecker, Stephan ; Toth, Gabor G ; Kirtane, Ajay J ; Troquay, Roel ; Stone, Gregg W ; Tulli, Mark ; Singh, Sunil ; Choi, James W ; Lung, Te-Hsin ; Brar, Somjot S ; Latib, Azeem ; Kedhi, Elvin ; Price, Matthew J ; Caputo, Ronald ; Chetcuti, Stanley ; Mylotte, Darren ; Mehran, Roxana ; Diderholm, Erik ; Kandzari, David E

BACKGROUND:

Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging.

METHODS:

The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups.

RESULTS:

Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar.

CONCLUSION:

Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653).

NON-STANDARD ABBREVIATIONS AND ACRONYMS:

BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy.

01 Jan 2024·The American journal of cardiology

Everolimus-Versus Zotarolimus-Eluting Stents in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights from the PROGRESS-CTO Registry

Article

Author: Jaber, Wissam ; Abi Rafeh, Nidal ; Azzalini, Lorenzo ; Nicholson, William ; Khelimskii, Dmitrii ; ElGuindy, Ahmed M ; Poommipanit, Paul ; Al Ogaili, Ahmed ; Brilakis, Emmanouil S ; Choi, James W ; Burke, M Nicholas ; Goktekin, Omer ; Gorgulu, Sevket ; Krestyaninov, Oleg ; Alexandrou, Michaella ; Mutlu, Deniz ; Rempakos, Athanasios ; Rangan, Bavana V ; Khatri, Jaikirshan J ; Rinfret, Stephane ; Sandoval, Yader ; Kearney, Kathleen E ; Ybarra, Luiz F ; Mastrodemos, Olga C

02 Nov 2023·Journal of biomolecular structure & dynamics

In silico drug repurposing and lipid bilayer molecular dynamics puzzled out potential breast cancer resistance protein (BCRP/ABCG2) inhibitors

Article

Author: Almansour, Nahlah Makki ; Abdelrahman, Alaa H. M. ; Ibrahim, Mahmoud A. A. ; Ismail Fagiree, Ekram

Multidrug resistance (MDR) is a fundamental reason for the fiasco of carcinoma chemotherapy. A wide variety of anticarcinoma drugs are expelled from neoplasm cells through the ATP-binding cassette (ABC) transporter superfamily, rendering the neoplasm cells resistant to treatment. The ATP-binding cassette transporter G2 (ABCG2, gene symbol BCRP) is an ABC efflux transporter that plays a key function in MDR to antineoplastic therapies. For these reasons, the identification of medicaments as BCRP inhibitors could assist in discovering better curative approaches for breast cancer therapy. Because of the deficiency of prospective BCRP inhibitors, the SuperDRUG2 database was virtually screened for inhibitor activity towards the BCRP transporter using molecular docking computations. The most potent drug candidates were then characterized utilizing molecular dynamics (MD) simulations. Furthermore, molecular mechanics-generalized Born surface area (MM-GBSA) binding affinities of the most potent drug candidates were estimated. Based on the MM-GBSA binding affinities throughout 150 ns MD simulations, three drugs-namely zotarolimus (SD002595), temsirolimus (SD003393), and glecaprevir (SD006009)-revealed greater binding affinities towards BCRP transporter compared to the co-crystallized BWQ ligand with ΔG_binding values of -86.6 ± 5.6, -79.5 ± 8.0, -75.8 ± 4.6 and -59.5 ± 4.1 kcal/mol, respectively. The steadiness of these promising drugs bound with BCRP transporter was examined utilizing their structural and energetical analyses throughout a 150 ns MD simulation. To imitate the physiological environment, 150 ns MD simulations for the identified drugs bound with BCRP transporter were conducted in the 1-palmitoyl-2-oleoyl-phosphatidylcholine lipid bilayer. These findings identify zotarolimus, temsirolimus and glecaprevir as auspicious anti-MDR drug leads that warrant further experimental assays.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Zotarolimus

14 May 2024

·www.biospace.com

EuroPCR 2024: Late-Breaking Data Demonstrate Significant Clinical Advantage of Elixir Medical’s DynamX Bioadaptor Over Standard of Care Drug-Eluting Stent at Two Years

Statistically significant reduction in hard clinical endpoints of TLF and TVF with DynamX; event rate flattened after one year in bioadaptor versus non-plateauing increase in DES In Left Anterior Descending (LAD) artery, bioadaptor demonstrated statistically significant 78% reduction in target lesion failure versus DES PARIS--(BUSINESS WIRE)-- Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced two-year results from the BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results, for the first time, demonstrate significant reduction in adverse events and clinical advantage of the DynamX bioadaptor in target lesion failure (TLF) and secondary endpoint of target vessel failure (TVF) driven by sustained low event rates with DynamX compared to a two-fold increase in DES. The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference in Paris. Clinical results show statistically significant benefit with DynamX bioadaptor over Resolute Onyx at two years: 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046). The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX compared to DES, respectively: Cardiovascular death (0% versus 1.8%) Target vessel myocardial infarction (0.9% versus 1.9) Target lesion revascularization (0.9% versus 2.3%) 68% reduction in TVF rate (1.9% versus 6.0%; p=0.029) in DynamX compared to DES Two-year lesion subset results: 78% reduction (1.9% vs.8.7%; p=0.028) in TLF rate in left anterior descending (LAD) artery lesions treated with DynamX bioadaptor versus treatment with DES Small vessels (<2.75mm) TLF rate was 0% vs. 3.5% in DynamX versus DES, respectively Long lesions (>23mm) TLF rate was 0% vs. 2.3% in DynamX versus DES, respectively “These two-year results from the BIOADAPTOR RCT trial are very exciting—unlike anything we’ve ever seen before—and represent a new treatment category for patients living with coronary artery disease. The TLF rate curve separation validates how the bioadaptor’s unique design and mechanism of action restores the vessel viability, including the LAD vessel. It does this by restoring hemodynamic modulation validating the previously demonstrated superior imaging outcomes at one year. These data show that bioadaptor offers sustained, very low event rates across all major endpoints, making it a superior option compared to DES,” said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “The 78% magnitude of reduction in clinical events in LAD lesions is particularly important, as the artery provides 50% of a heart muscle’s blood supply and undergoes significant hemodynamic movement during every cardiac cycle. Restoring its function is clearly of significant benefit.” The DynamX bioadaptor is different from current standard of care therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. The locked phase establishes maximum flow lumen and restores blood flow. Unique to bioadaptor, the unlocked and separation phase of bioadaptor’s helical strands releases the vessel while maintaining the established blood flow lumen. The final phase provides adaptive dynamic support after the unlocking and separation phase to restore vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has shown evidence of plaque stabilization and regression in the lesion. “We are beyond thrilled with these findings from the BIOADAPTOR RCT,” said Motasim Sirhan, CEO of Elixir Medical. “Never before have we seen a vascular technology that addresses the limitations of existing revascularization therapies by restoring artery hemodynamic modulation and stabilizing or regressing plaque volume, as we have with DynamX bioadaptor. These exceptional patient clinical outcomes further validate that the bioadaptor is truly a transformative technology for coronary artery disease treatment.” About BIOADAPTOR RCT Trial The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial (RCT) comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor System The DynamX bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow up. The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S. About Elixir Medical Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn and X. View source version on businesswire.com: Contacts Emma Yang, Health+Commerce Email: emma@healthandcommerce.com Source: Elixir Medical View this news release online at:

Clinical ResultClinical StudyAHA

30 Apr 2024

·www.biospace.com

Elixir Medical To Announce Data from Three Platforms Designed to Transform Cardiovascular Disease Treatment at EuroPCR 2024, Including Two Late-Breakers

—Late-breaking BIOADAPTOR RCT data to highlight two-year clinical outcomes of the DynamX Bioadaptor, the first therapy designed to restore coronary artery hemodynamic modulation and improve PCI Outcomes— —Primary endpoint data of clinical results of novel LithiXTM Hertz Contact Intravascular Lithotripsy technology designed to simplify fragmentation and treatment of a broad range of complex calcified lesions— —Late-breaking one-year results from DESyne BDS Plus RCT of the novel TRx site-specific antithrombotic therapeutic designed to eliminate compromise between managing patient thrombotic and bleeding risk— MILPITAS, Calif.--(BUSINESS WIRE)-- Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, announced it will present long-term two-year clinical results from its BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), an international, single-blind study comparing the novel DynamXⓇ Coronary Bioadaptor System designed to restore coronary artery hemodynamic modulation and vessel function, compared with a standard of care drug-eluting stent (DES) therapy, as a late-breaker session at EuroPCR 2024 in Paris on May 14. “There remains a large unmet need for transformative technology in cardiovascular intervention to address limitations of coronary artery disease (CAD) treatments such as maintaining the established artery flow lumen, restoring vessel hemodynamic modulation, and stabilizing or regressing plaque to deliver durable and incremental clinical benefit. In the absence of restoring artery function, today we see 20% MACE within 5 years1 and 50% by 10 years2 after PCI attributable to non-plateauing annual adverse events with DES,”3 said Motasim Sirhan, CEO of Elixir Medical. “We are very pleased with our 12-month data from the BIODAPTOR RCT study, which demonstrated restoration of vessel motion and function with better effectiveness than standard of care, DES, and we are thrilled to unveil the two-year clinical outcomes to solidify the strong body of clinical evidence supporting the DynamX Bioadaptor in delivering sustained superior clinical outcomes for patients.” Elixir Medical will also unveil primary clinical, angiographic, and OCT imaging outcomes from the PINNACLE I clinical study evaluating its novel LithiXTM calcium fragmentation technology based on Hertz Contact Intravascular Lithotripsy. Featured as an Innovation Session presentation, the clinical results are intended to demonstrate safety and efficacy of Elixir’s lithotripsy technology designed to simplify treatment of a broad range of complex calcified lesions while advancing safety and efficacy of calcium modification. Additionally, Elixir Medical will share late-breaking 12-month outcomes of its TRx site-specific antithrombotic therapeutic from the DESyne BDS Plus RCT, a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the world’s first triple-drug site-specific antithrombotic therapy (TRx) on a DES compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions. Full list of presentation details: Late-breaker presentation details: New coronary devices (DES / BRS / DCB) Title: “Site-specific antithrombotic therapy: DESyne BDS Plus study 12-month outcomes” Principal investigator: Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil Date: Tuesday, May 14, 2024 Time: 15:15 - 16:45 CEST Location: Theatre Havane Late-breaker presentation details: New coronary devices (DES / BRS / DCB) Title: “Two-year clinical outcomes of the BIOADAPTOR RCT study” Principal investigator: Shigeru Saito, M.D., director of the Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital, Kanagawa, Japan Date: Tuesday, May 14, 2024 Time: 15:15 - 16:45 CEST Location: Theatre Havane Innovations / CV pipeline session: Other coronary interventions Title: “Hertz contact intravascular lithotripsy: PINNACLE I study primary outcomes” Presenter: Stefan Verheye, MD, PhD, senior interventional cardiologist at Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium Date: Thursday, May 16, 2024 Time: 14:45 - 16:15 CEST Location: Room 352A E-Poster: Coronary interventions Title: “INFINITY-SWEDEHEART: an innovative registry-based RCT comparing DynamX bioadaptor to DES” Presenter: David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE. Location: The Poster Lab - Level 3 Case in point session Title: “Cracking the calcium code - Novelty and utility of Hertz Contact intravascular lithotripsy” with discussion on the company’s novel HC-IVL system and human experience Presenters: Stefan Verheye, M.D., Roxana Mehran, M.D., Valeria Paradies, M.D., Stefano Galli, MD, Johan Bennett, M.D. Date: Wednesday, May 15th, 2024 Time: 13:30 to 14:15 CEST Location: Room 251 Case in point session Title: “Restoring vessel physiology drives outcomes - The Bioadaptor experience” which will highlight the bioadaptor’s unique mechanism of action and real-world global clinical experience with the technology Presenters: Flavio L. Ribichini, M.D., Johan Bennett, M.D., Mirvat Alasnag, M.D., Michal Hawranek, M.D., Ganapathi Palaniappan, M.D., Anthony Siu-Fung Wong, M.D Date: Thursday, May 16, 2024 Time: 13:30 to 14:15 CEST Location: Room 243 About BIOADAPTOR RCT Trial The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting Bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients. Both arms had large randomized multi-modality imaging subgroups of 100 patients each powered to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, and adaptive flow volume. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX Bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About PINNACLE I Trial The PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating safety, effectiveness, and performance of the LithiX Hertz Contact Lithotripsy Catheter for the treatment of calcified lesions. The trial includes up to 60 patients across 5 sites in Belgium and Netherlands. Angiographic imaging outcomes of all 60 patients and a subset of 30 patients by OCT are scheduled to undergo independent core lab analysis. Primary safety and effectiveness outcomes will be reported at 30 days and 6 months. About the DESyne BDS Trial The DESyne BDS Plus Randomized Clinical Trial (RCT) is a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the TRx site-specific antithrombotic therapeutic on DESyne BDS Plus Triple Drug-Eluting Coronary Implant compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions. The trial includes 202 patients across 14 sites in Europe, New Zealand and Brazil. An imaging subset of 58 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first six months. Data collection will continue through three years. About Elixir Medical Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn. References: 1. Iqbal et al. Final 5-Year Report of the RESOLUTE All-comers Trial. Circ Cardiovasc Interv. 2015. 2. Kufner et al. ISAR-TEST 4 Trial. Circulation, 2019. 3. Madhavan MV et al. J Am Coll Cardiol 2020;75:590-604.

Clinical ResultClinical Study

04 Oct 2023

·www.biospace.com

Elixir Medical Completes Submission of DynamX Coronary Bioadaptor System to Japan’s PMDA Agency for Regulatory Approval

Once approved, the DynamX Coronary Bioadaptor System would become the first percutaneous coronary intervention (PCI) treatment available in Japan to demonstrate restoration of vessel motion and function MILPITAS, Calif.--(BUSINESS WIRE)-- Elixir Medical, a developer of disruptive cardiovascular technologies, announced submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) for the approval of the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease (CAD). DynamX coronary bioadaptor was developed to overcome the limitations of drug-eluting stents (DES) and bioresorbable scaffolds (BRS). DynamX is a novel coronary implant designed to unlock the scaffold, uncage the vessel, and provide the essential dynamic support after uncaging to return normal vessel motion and function after percutaneous coronary intervention (PCI). In a randomized controlled trial versus DES, the unique mechanism of action has shown reduced target lesion failure (TLF) rates and restored vessel pulsatility, translating to increased blood flow, improved vessel lumen diameter, and reduced plaque progression. “Our submission for approval in Japan is an exciting milestone for the company and industry. The DynamX coronary bioadaptor represents a culmination of major design and manufacturing breakthroughs and three clinical trials consistently demonstrating differentiated functional performance compared to the standard of care,” said Motasim Sirhan, CEO of Elixir Medical. “Coronary artery disease treatment with stents has seen no major innovation in over 20 years, and we are thrilled to challenge the current standard of care by bringing our technology to physicians and patients around the world.” “Drug-eluting stents (DES) have served an important role in the treatment of coronary artery disease, but have yet to overcome many challenges, including restricting vessel motion and function, mechanical failure, and progression of plaque,” said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, and principal investigator of the BIOADAPTOR RCT trial. “What we have seen with the DynamX in the 12-month BIOADAPTOR RCT data exceeded our expectations against the current standard of care—the Resolute Onyx™ DES—in clinical outcomes, and for the first time ever demonstrated restoration of vessel pulsatility, motion and function by uncaging the vessel while providing the needed support after uncaging. The findings collectively point to a technology standard not seen before that I believe is of great benefit to patients.” About DynamX® Coronary Bioadaptor System DynamX coronary bioadaptor is the first coronary implant technology designed to unlock the scaffold, uncage the vessel, and restore sustained normal vessel motion and function after PCI by maintaining dynamic support of the diseased vessel after its uncaging. With this unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates. The DynamX Coronary Bioadaptor System is CE marked. Not available for sale in the U.S. About the BIOADAPTOR RCT Trial The BIOADAPTOR RCT is an international, single-blinded, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients. Both arms included a large randomized multi-imaging modality subgroup of 100 patients powered to document standard effectiveness benchmarks, and the new effectiveness benchmarks of vessel motion and function. The primary and secondary endpoints were presented at a late breaking trial session at EuroPCR 2023. The BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX bioadaptor clinical evidence program consisting of several clinical trials involving over 9,000 patients, including the INFINITY SWEDEHEART RCT (n=2400) which completed enrollment in July, and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About Elixir Medical Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn and X, formerly known as Twitter. View source version on businesswire.com: Contacts Erin Crowley, Health+Commerce Tel.: 334-524-9871 Email: erin@healthandcommerce.com Source: Elixir Medical Corporation View this news release online at:

Clinical Study

100 Deals associated with Zotarolimus

External Link

KEGG	Wiki	ATC	Drug Bank
D06669	Zotarolimus	L04AA	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Coronary Restenosis	CA	AbbVie AS	16 May 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 1	US	Medtronic Plc	-
Vascular restenosis	Phase 1	US	AbbVie AS	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03647475 (CTgov)	Not Applicable	Hemorrhage \| Coronary Artery Disease	752	Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT	ivaddlznnq(jqszdfldvz) = wtkflxrcmp ieofkvrvfa (uxmwywcnoy, yxzidnfjco - mcomgdseld) View more	-	06 May 2021
SORT OUT VI (Pubmed \| JACC Cardiovasc Interv)	Not Applicable	Coronary Artery Disease	-	Durable-Polymer Zotarolimus-Eluting Stent	ojrsolhxqa(gcivhvucop) = bjlnpggrrd uabbmeqpxq (xrdbvvyerd ) View more	Positive	13 Feb 2017
				Biodegradable-Polymer Biolimus-Eluting Stent	ojrsolhxqa(gcivhvucop) = rdfqlntqtu uabbmeqpxq (xrdbvvyerd ) View more
Pubmed \| J Am Coll Cardiol	Not Applicable	Coronary Artery Disease	-	Zotarolimus-eluting stent (ZES)	rvagwqstko(mmoyxfektd) = mmvvpizfhq gidhdjkyzf (yamlkyjkyp ) View more	-	03 Dec 2013
				Zotarolimus (Everolimus-eluting stent (EES))	rvagwqstko(mmoyxfektd) = edtcitmojh gidhdjkyzf (yamlkyjkyp ) View more
E-Five Registry (Pubmed \| Catheter Cardiovasc Interv)	Not Applicable	-	-	Endeavor zotarolimus-eluting stent	kujpcjvvvo(mwlyewiwrh) = twetbqkayp twvgoydzwq (ltfhutcdmq ) View more	-	01 Jun 2011
Pubmed \| JACC Cardiovasc Interv	Not Applicable	Coronary Artery Disease	401	Zotarolimus	cfepqaxyrg(smmetbeqqr) = fnrlduswie gpvqgqbqmi (folwtjjyxp ) View more	Negative	01 Oct 2008
				Zotarolimus	cfepqaxyrg(smmetbeqqr) = wunflrpety gpvqgqbqmi (folwtjjyxp ) View more

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