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NCT07912541
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Conditions: Coronary Artery Disease, De Novo Stenosis Lesion, Coronary Stent Implantation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Advanced MedTech Solutions Pvt. Ltd.
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.
Eligibility Criteria
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) \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 \700.000 cells/mm3 or a WBC\
Source: ClinicalTrials.gov (NCT07912541). StuddyBuddy aggregates publicly available trial information.
