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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.
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-
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;
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.
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.
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.
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
To estimate
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RisoR Crest Everolimus Eluting Coronary Stent System | Other | The RisoR Crest Everolimus Eluting Coronary Stent System is coated with a drug and biodegradable polymer coating formulation consisting of Everolimus drug, the active ingredient, and biodegradable polymers. This is intended to supply continuous release of Everolimus drug after stent implantation over an extended period of time. The unique ultrasonic atomization drug technology is combined with acoustic activation and carrier stream technologies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Stent | Device | RisoR Crest Everolimus Eluting Coronary Stent System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | 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. | 360 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TLF (Equivalent of DoCE) |
| 30, 180 and 270 days |
| Incidence of POCE |
| Measure | Description | Time Frame |
|---|---|---|
| QCA Endpoints | In-stent and in-segment % diameter stenosis (DS) | 270 days |
| QCA Endpoints | Minimum Lumen Diameter (MLD) | 270 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dinesh Rajendra Patil | Contact | +91-8149037128 | dinesh.patil@polymedicure.com | |
| Priyadarshini Arambam | Contact | +91-9910990347 | regulatory@clicebo.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Praveen Chandra, DM Cardiology | Medanta-The Medicity, Gurugram, Haryana, India | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39270739 | Background | 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. | |
| 29654119 |
| Label | URL |
|---|---|
| World Heart Report 2023: Confronting the World's Number One Killer. | View source |
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Post-market study in India and Pre-market study in Europe.
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| 30, 180, 270 and 360 days |
| Incidence of MACE |
| 30, 180, 270 and 360 days |
| Target Vessel Failure (TVF) | Target Vessel Failure (TVF) | 30, 180, 270 and 360 days |
| Non -Target Vessel related Myocardial Infarction | Non -Target Vessel related Myocardial Infarction | 30, 180, 270 and 360 days |
| Stent thrombosis | Stent thrombosis as per | 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 | 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 | Day 0 |
| Procedural 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 | Day 3 |
| QCA Endpoints | Late Lumen Loss | 270 Days |
| QCA Endpoints | Angiographic binary restenosis | 270 Days |
| OCT Endpoints | Diameter Stenosis % | 270 Days |
| OCT Endpoints | Proportions of in-stent and in-segment binary restenosis | 270 Days |
| OCT Endpoints | Proportion of Struts uncovered and malapposed | 270 Days |
| OCT Endpoints | Area restenosis | 270 Days |
| OCT Endpoints | Neo-intimal hyperplasia | 270 Days |
| Result |
| 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/CIRCINTERVENTIONS.117.006034. |
| 30165437 | Result | 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/eurheartj/ehy394. No abstract available. |
| 28795481 | Result | 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. |
| 23323902 | Result | 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. |
| 23473109 | Result | 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. |
| 23922145 | Result | 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. |
| 24036025 | Result | 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. |
| 15500897 | Result | McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9. |
| 25820058 | Result | Mehra A, Mohan B. Value of FFR in clinical practice. Indian Heart J. 2015 Jan-Feb;67(1):77-80. doi: 10.1016/j.ihj.2015.02.025. Epub 2015 Mar 14. |
| 32227755 | Result | Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30. |
| 17387127 | Result | Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26. |
| 19228612 | Result | Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. |
| 16267256 | Result | Mauri L, Orav EJ, Candia SC, Cutlip DE, Kuntz RE. Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials. Circulation. 2005 Nov 1;112(18):2833-9. doi: 10.1161/CIRCULATIONAHA105.570093. |
| 27326098 | Result | Hou XM, Han WZ, Qiu XB, Chen H, Fang WY. Safety and effectiveness of drug-eluting stents in Chinese patients with coronary artery disease with off- and on-label indications: results from a single-centre registry. Heart Asia. 2013 Jan 24;5(1):101-5. doi: 10.1136/heartasia-2013-010316. eCollection 2013. |
| 30442 | Result | Rosenbaum M. The role of long term beta-blockade after myocardial infarction: Paper 2. Aust Fam Physician. 1978 Jun;Suppl:34-7. |
| Cardiovascular diseases statistics | View source |
| India Coronary Stents Market. Coherent Market Insights | View source |
| Dual Antiplatelet Therapy for 6 Months vs 12 Months After New-generation Drug-eluting Stent Implantation: Matched Analysis of ESTROFA-DAPT and ESTROFA-2 | View source |
| CSI: Cardiology Update 2014 | View source |
| The East-West late lumen loss study: Comparison of angiographic late lumen loss between Eastern and Western drug-eluting stent study cohorts | View source |
| MEDICAL DEVICES RULES, 2017 | View source |
| Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/E | View source |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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