Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT07098195
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT07098195
Study Brief:
Protocol Section:
NCT07098195