NCT02406326

An Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10 patients per centre involving approximately 25 centres). Patients will be followed up clinically for twelve months post-procedure at 1 month, 6 months \& 12 months. All patients will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years 3 \& 5 post-implant.

Detailed description

This is a multi centre, prospective observational study. 250 patients will be enrolled in the study. 10 patients per centre involving approximately 25 centres. All the patients will be followed for twelve months post-procedure. All patients will have a repeat angiography assessment at 8 months. An additional clinical follow-up will be maintained for years 3 \& 5 post-implant. Approximately 250 patients with obstructive coronary artery disease with a vessel size between ≥2.5 to ≤3.5 mm in diameter by visual estimate and who meet all eligibility criteria will be treated with the Sirolimus Eluting Stent. It is anticipated that the total length of the study will be 16 months: 4 months to complete patient enrollment and 12 months for angiographic follow-up.

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2009-08-27
• Primary completion: 2016-12-27
• Completion: 2016-12-27
• First posted: 2015-04-02
• Last updated: 2018-04-11

Locations

11 sites across 1 country: India