An observational registry study of Advapro Coronary Stent System in coronary artery diseasedpatients of Indian and European population.
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2024/07/069702
- Lead Sponsor
- Advanced MedTech Solutions Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Greater than 18 years.
2. All (Males, Females, Transgenders, Non-binary).
3. Patient or legally authorized representative
(LAR) agrees to participation by signing the
informed consent form.
4. Patient with coronary artery disease Eligible
for percutaneous coronary intervention (PCI).
5. Patient with coronary artery disease having one
or more de novo stenosis lesion in two native
coronary artery with a visually estimated diameter
stenosis greater than or equal 70 percent.
6. Patients with Reference vessel diameter of 2.5
to 3.50 mm.
7. Patients with lesion length less than or equal 36 mm.
1 Ethical- Pregnant and lactating females
2 Condition- Patients requiring staged procedure
3 Condition- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 percent
4 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
5 Condition- Current medical condition with a life expectancy of less than 12 months
6 Condition- Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
7 Condition- Patient has current unstable arrhythmias
8 Procedural- Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
9 Procedural- Patients with Chronic Total Occlusion in two or more vessels
10 Procedural- Patients with Ostial lesions (within 5mm of vessel origin).
11 Procedural- Patients with Bifurcation lesions that include a side branch greater than 2 mm diameter
12 Procedural- Unprotected Left Main Coronary Artery lesion
13 Condition- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
14 Condition- Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine greater than 2 mg per dl or 150 µmol per L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure
15 Condition- Patients with platelet count less than 100 cells per mm3 or greater than 700 cells per mm3 or a WBC less than 3 cells per mm3
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite Endpoint <br/ ><br>MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)Timepoint: 1 Year
- Secondary Outcome Measures
Name Time Method