CTRI/2024/07/069702
Not yet recruiting
未知
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
Advanced MedTech Solutions Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Sponsor
- Advanced MedTech Solutions Private Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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