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NCT07912541

ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)

Sponsor: Advanced MedTech Solutions Pvt. Ltd.

View on ClinicalTrials.gov

Summary

A prospective, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population. To evaluate the performance of ADVA ACE Everolimus Eluting Stent, follow up indicated by MACE at 6 months. Of the 110, 40 patients will be assigned to European population, and 70 patients will be assigned to Indian population. QCA is applicable to all Indian patients while OCT applicable for 10 Indian patients only at baseline and 6-months follow-up visit. A QCA Analysis will be performed on all 70 patients in Indian population \& 10 Indian patients only. Interval (Days) for patients visit at Day 0, Day 30±14, Day 180±14 and Day 360±14.

Official title: A Prospective, Global, Multi-centre, Single-arm Clinical Study to Evaluate the Safety and Performance of ADVA ACE Everolimus elutiNg Coronary Stent System in Coronary Artery Disease in Indian & European Population (ADVANCE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-11

Completion Date

2029-05

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Coronary Artery Disease De Novo Stenosis Lesion Coronary Stent Implantation

Interventions

DEVICE

ADVA ACE Everolimus Eluting Coronary Stent System

ADVA ACE - Everolimus Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (coronary stent system) and a drug product (a formulation of Everolimus contained in a biodegradable polymer coating). is uniquely designed with a low polymer load, abluminal coating and bioabsorbable polymer matrix which may reduce the risk of thrombosis and the need for prolonged dual antiplatelet therapy.

Inclusion Criteria: 1. Age ≥18 years 2. Gender: All (Males, Females, Transgenders, Non-binary) 3. ICF: 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 current ESC / AHA/ WCC or hospital's approved guidelines. 5. Patient with coronary artery disease having de novo lesion in native coronary arteries with a visually estimated diameter stenosis ≥50 %. 6. Patients with Reference vessel diameter of 2.25 to 4.5 mm. 7. Patients with lesion length ≤36 mm. Exclusion Criteria: 1. Pregnant and/or lactating females. 2. Patients under judicial protection, tutorship, curatorship, imprisonment etc (for Europe only). 3. Patients requiring staged procedure. 4. Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30%. 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. Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure. 8. Patient has current unstable arrhythmias. 9. Patients previously treated with PCI or CABG for any coronary artery lesion revascularization. 10. Patients with Chronic Total Occlusion or In-Stent Restenosis lesion. 11. Patients with Ostial Lesions (within 5.0mm of vessel origin). 12. Patients with Bifurcation lesions that include a side branch \>2.0 mm diameter. 13. Unprotected Left Main Coronary Artery lesion. 14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist. 15. 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 1 year of the index procedure. 16. Patients with platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC\<3.000 cells/mm3. 17. Currently participating in another clinical trial.