NCT06300268Not yet recruiting
Advapro Coronary Stent System in Coronary Artery Diseased Patients.
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)
Source: ClinicalTrials.gov · Last updated 8 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- Jun 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Advanced MedTech Solutions Pvt. Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT06300268
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Jun 2024 to the primary completion date, Jun 2026
- 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
- Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
Other illness
- 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
- Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
Lab values
- Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30%
- 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
Other
- Ethical : Pregnant and lactating females
- Patients requiring staged procedure
- 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
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 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
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.