NCT07912541Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
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)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 21 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Advanced MedTech Solutions Pvt. Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT07912541
What you commit to
- Study type: Interventional
- Planned participants: 110
- From Nov 2026 to the primary completion date, Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously treated with PCI or CABG for any coronary artery lesion revascularization.
Other illness
- 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.
- Current medical condition with a life expectancy of less than 12 months.
- Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure.
- Patient has current unstable arrhythmias.
Lab values
- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30%.
- 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.
- Patients with platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC\<3.000 cells/mm3.
Other
- Pregnant and/or lactating females.
- Patients under judicial protection, tutorship, curatorship, imprisonment etc (for Europe only).
- Patients requiring staged procedure.
- Patients with Chronic Total Occlusion or In-Stent Restenosis lesion.
- Patients with Ostial Lesions (within 5.0mm of vessel origin).
- Patients with Bifurcation lesions that include a side branch \>2.0 mm diameter.
- Unprotected Left Main Coronary Artery lesion.
- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist.
- Currently participating in another clinical trial.
Who the study is looking for
- Age ≥18 years
- Gender: All (Males, Females, Transgenders, Non-binary)
- ICF: Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.
- Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per current ESC / AHA/ WCC or hospital's approved guidelines.
- Patient with coronary artery disease having de novo lesion in native coronary arteries with a visually estimated diameter stenosis ≥50 %.
- Patients with Reference vessel diameter of 2.25 to 4.5 mm.
- Patients with lesion length ≤36 mm.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.