Advapro Coronary Stent System in Coronary Artery Diseased Patients.

Launched by ADVANCED MEDTECH SOLUTIONS PVT. LTD. · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of heart stent called the AdvaPro Sirolimus Eluting Stent, which is used to open blocked arteries in patients with coronary artery disease. The main goal of the study is to see how safe and effective this stent is over a period of nine months. The trial will involve 120 participants, with 40 from Europe and 80 from India, who have specific types of blockages in their coronary arteries that need treatment.

To be eligible for the trial, participants must be over 18 years old and have coronary artery disease suitable for a procedure to open their arteries. They should have significant blockages that are at least 70% narrowed and meet other guidelines related to the size and complexity of their condition. Throughout the study, participants will have several follow-up visits to monitor their progress, and those in the Indian group will undergo special imaging tests to evaluate the stent's performance. It’s important to note that certain individuals, such as pregnant women or those with specific health issues, may not qualify for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Ethical : Pregnant and lactating females
• • Patients requiring staged procedure
• • Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) \<30%
• • 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
• • Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
• • 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
• • Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
• • 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