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NOT YET RECRUITING

NCT06300268

Advapro Coronary Stent System in Coronary Artery Diseased Patients.

Sponsor: Advanced MedTech Solutions Pvt. Ltd.

View on ClinicalTrials.gov

Summary

A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population. To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months. Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit. A QCA Analysis will be performed on minimum 48 patients in Indian population only. Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.

Official title: A Prospective, MulticentRe, Pilot Study to Evaluate the Safety and Performance of The AdvaPro Sirolimus Eluting CorOnary Stent System in Coronary ARtery Stenosis in Indian and European Population(RESTORE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-06

Completion Date

2026-12

Last Updated

2024-03-08

Healthy Volunteers

Conditions

Coronary Artery Disease De Novo Stenosis Lesion Coronary Stent Implantation

Interventions

DEVICE

AdvaPro Sirolimus Eluting Coronary Stent System

Cardiac Stent

Inclusion Criteria: * Age \>18 years * Gender : All (Males, Females, Transgenders, Non-binary) * ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form. * Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI) * Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70% * Condition - Angiographic : Patients with Reference vessel diameter of 2.5 \~ 3.50 mm * Condition - Angiographic : Patients with lesion length ≤ 36 mm Exclusion Criteria: * Ethical : Pregnant and lactating females * Patients requiring staged procedure * Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30% * Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media * Condition : Current medical condition with a life expectancy of less than 12 months * Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure * Condition : Patient has current unstable arrhythmias * Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization * Procedural : Patients with Chronic Total Occlusion in two or more vessels * Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin). * Procedural : Patients with Bifurcation lesions that include a side branch \>2.0 mm diameter * Procedural : Unprotected Left Main Coronary Artery lesion * Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist * Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine \>2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure * Condition : Patients with platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3