To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System

Официальное название

An OPen-label, Multicentre, Single Arm, Clinical InvestigatIon to Evaluate PerFormance and Safety of RIsoR Crest EveRolimus Eluting Coronary Stent System

Обзор

The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.

Подробное описание

The clinical study to evaluate safety and performance of RisoR Crest Everolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian (post market) and European (pre-market) Population. Enrolment of up to 1960 participants (100 QCA+50 OCT) in India and 40 in Europe is planned in the current study.

The Primary objective of the study is to evaluate the safety and performance of RisoR Crest Everolimus Eluting Coronary Stent System at 360 days follow up indicated by the Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, Target Vessel oriented Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.

The secondary objectives are-

1. To estimate incidence of Device Oriented composite end point (DoCE) which is equivalent of Target Lesion Failure (TLF), a hierarchical composite of Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 30, 180 and 270 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System; 2. Patient oriented composite end point (PoCE), which is a hierarchical composite of any death, any myocardial infarction, any stroke and any coronary revascularization at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System. 3. Major Adverse Cardiac Events (MACE), a hierarchical composite of cardiovascular death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System. 4. Target Vessel Failure (TVF), a hierarchical composite of cardiovascular death, Target Vessel related Myocardial Infarction (TVMI) and Clinically indicated Target Vessel Revascularization (Ci-TVR) at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System. 5. Stent thrombosis by ARC 2 and Latency Definitions at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System and 6. To estimate

1. Device success, defined as achievement of a final residual diameter stenosis of ≤ 20% (site - reported), using the assigned device only, with Successful deployment of stent and complete retrieval of delivery system without coronary dissection, device disintegration, visible stent malapposition. 2. procedure success, defined as achievement of a final diameter stenosis ≤ 20%(site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay. 7. To estimate angiographic parameters of performance of RisoR Crest Everolimus Eluting Coronary Stent System as defined by Late Lumen Loss and percentage Diameter Stenosis at 270 days. 8. To estimate percentage of cover struts by OCT at 270 days.

All participants will be followed up at 30±8 days, 180±8 days, 270±10 days and 360±14 days.

For QCA and and OCT sub sets (only for India) all participants will have a mandatory clinic visit at 9 months (270±10 days) for a check angiography and OCT procedure.

Вмешательства

• Устройство Coronary Stent
  RisoR Crest Everolimus Eluting Coronary Stent System

Первичные конечные точки

• Target Lesion Failure (TLF) [Срок оценки: 360 Days]

Вторичные конечные точки (8)

• Incidence of TLF (Equivalent of DoCE) [Срок оценки: 30, 180 and 270 days]
• Incidence of POCE [Срок оценки: 30, 180, 270 and 360 days]
• Incidence of MACE [Срок оценки: 30, 180, 270 and 360 days]
• Target Vessel Failure (TVF) [Срок оценки: 30, 180, 270 and 360 days]
• Non -Target Vessel related Myocardial Infarction [Срок оценки: 30, 180, 270 and 360 days]
• Stent thrombosis [Срок оценки: a. Academic Research Consortium [ARC] 2 definitions - Definite/probable b. As per latency - Acute (0-24 hours), Subacute (24 hours- 30 days) and late (30-360 days)]
• Device success [Срок оценки: Day 0]
• Procedural success [Срок оценки: Day 3]

Критерии участия

Критерии включения

• Age more than 18 years
• All Genders (Males, Females, Transgenders, Non binary)
• Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.
• Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospital's standard practices guidelines for PCI (For Europe, as per ESC guidelines)
• Patient with coronary artery disease having one or more de novo or in - stent stenosis lesions in native coronary artery with a visually estimated diameter stenosis ≥70%.
• Patients with Reference vessel diameter of 2.0 to 4.5 mm
• Patients with lesion length less than 48 mm

Критерии исключения

• Pregnant and lactating females
• Candidates for emergency bypass Surgery
• Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security, imprisonment etc.)
• Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
• Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
• Current medical condition with a life expectancy of less than 12 months
• Patient who have current unstable arrhythmias
• Patient previously undergone CABG.
• Left Main Coronary Artery lesion
• Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine >2.0mg/dl or 150 μmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 360 days of the index procedure
• Patients with platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Chong B, Jayabaskaran J, Jauhari SM, Chan SP, Goh R, Kueh MTW, Li H, Chin YH, Kong G, Anand VV, Wang JW, Muthiah M, Jain V, Mehta A, Lim SL, Foo R, Figtree GA, Nicholls SJ, Mamas MA, Januzzi JL, Chew NWS, Richards AM, Chan MY. Global burden of cardiovascular diseases: projections from 2025 to 2050. Eur J Prev Cardiol. 2025 Aug 25;32(11):1001-1015. doi: 10.1093/eurjpc/zwae281. PMID 39270739
• Lee SWL, Tam FCC, Lam SCC, Kong SL, Shea CP, Chan KKW, Wong MKL, Chan MPH, Wong AYT, Yung ASY, Lam YM, Zhang LW, Wu KKY, Mintz GS, Maehara A. The OCT-ORION Study: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-Eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss. Circ Cardiovasc Interv. 2018 Apr;11(4):e006034. doi: 10.1161/CIRCINTER PMID 29654119
• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurhear PMID 30165437
• Mahmud E, Pourdjabbar A, Ang L, Behnamfar O, Patel MP, Reeves RR. Robotic technology in interventional cardiology: Current status and future perspectives. Catheter Cardiovasc Interv. 2017 Nov 15;90(6):956-962. doi: 10.1002/ccd.27209. Epub 2017 Aug 10. PMID 28795481
• Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013 Jan 17;368(3):254-65. doi: 10.1056/NEJMra1210816. No abstract available. PMID 23323902
• Prati F, Uemura S, Souteyrand G, Virmani R, Motreff P, Di Vito L, Biondi-Zoccai G, Halperin J, Fuster V, Ozaki Y, Narula J. OCT-based diagnosis and management of STEMI associated with intact fibrous cap. JACC Cardiovasc Imaging. 2013 Mar;6(3):283-7. doi: 10.1016/j.jcmg.2012.12.007. PMID 23473109
• Bangalore S, Amoroso N, Fusaro M, Kumar S, Feit F. Outcomes with various drug-eluting or bare metal stents in patients with ST-segment-elevation myocardial infarction: a mixed treatment comparison analysis of trial level data from 34 068 patient-years of follow-up from randomized trials. Circ Cardiovasc Interv. 2013 Aug;6(4):378-90. doi: 10.1161/CIRCINTERVENTIONS.113.000415. Epub 2013 Aug 6. PMID 23922145
• Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Genereux P, Branzi A, Stone GW. Stent thrombosis with drug-eluting stents: is the paradigm shifting? J Am Coll Cardiol. 2013 Nov 19;62(21):1915-1921. doi: 10.1016/j.jacc.2013.08.725. Epub 2013 Sep 11. PMID 24036025

Идентификаторы

NCT: NCT07098195 · CSPL/REG/2025/02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗