NCT03721614

Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.

A Prospective, Active Control, Open-label, Multinational, Randomized Clinical Trial Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems to Evaluate Safety and Performance in Patients With Long de Novo Lesions.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\]. The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures. All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure. 10% of the patients \[(2:1) BioMime™ Morph (13) vs. Xience (7)\] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. \[Time Frame: Post-procedure and 6 months (±14 days)\]

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	BioMime™ Morph - Sirolimus Eluting Coronary Stent System	Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\].
DEVICE	Xience family Everolimus Coronary Stent Systems	Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\].

Timeline

• Start date: 2019-09-15
• Primary completion: 2021-12-01
• Completion: 2022-06-22
• First posted: 2018-10-26
• Last updated: 2019-08-14