Coronary Artery Disease, Coronary Artery Stenosis, Percutaneous Coronary Intervention, de Novo Lesions in Native Coronary Arteries
Conditions
Keywords
RisoR Crest, Everolimus Eluting Stent, Poly Medicure Private Limited, Drug Eluting Stent, Biodegradable Polymer, Pacifier
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.
Interventions
DEVICECoronary Stent
RisoR Crest Everolimus Eluting Coronary Stent System
Sponsors
Poly Medicure Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Post-market study in India and Pre-market study in Europe.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Age more than 18 years 2. All Genders (Males, Females, Transgenders, Non binary) 3. Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form. 4. 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) 5. 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%. 6. Patients with Reference vessel diameter of 2.0 to 4.5 mm 7. Patients with lesion length less than 48 mm
Exclusion criteria
1. Pregnant and lactating females 2. Candidates for emergency bypass Surgery 3. 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.) 4. Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent 5. 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 6. Current medical condition with a life expectancy of less than 12 months 7. Patient who have current unstable arrhythmias 8. Patient previously undergone CABG. 9. Left Main Coronary Artery lesion 10. 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 11. Patients with platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 360 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of TLF (Equivalent of DoCE) | 30, 180 and 270 days | 1. Cardiovascular Death 2. Target vessel Myocardial Infarction (TV-MI) and 3. Clinically indicated Target Lesion Revascularization (Ci-TLR). |
| Incidence of POCE | 30, 180, 270 and 360 days | 1. All cause death 2. Any stroke 3. Any myocardial infarction (includes non-target vessel territory) 4. Any revascularization |
| Incidence of MACE | 30, 180, 270 and 360 days | 1. Cardiovascular death 2. Myocardial Infarction (MI) 3. Target Vessel Revascularization (TVR) |
| Target Vessel Failure (TVF) | 30, 180, 270 and 360 days | Target Vessel Failure (TVF) |
| Device success | Day 0 | 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 |
| Procedural success | Day 3 | 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 |
| Non -Target Vessel related Myocardial Infarction | 30, 180, 270 and 360 days | Non -Target Vessel related Myocardial Infarction |
| Stent thrombosis | 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) | Stent thrombosis as per |
Other
| Measure | Time frame | Description |
|---|---|---|
| OCT Endpoints | 270 Days | Diameter Stenosis % |
| QCA Endpoints | 270 days | In-stent and in-segment % diameter stenosis (DS) |
Contacts
Primary ContactDinesh Rajendra Patil
Backup ContactPriyadarshini Arambam
Outcome results
None listed