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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.

NCT03721614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-08-14

No results posted yet for this study

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

Interventions

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 \[BioMime™ Morph (n=133) vs. XIENCE family (n=67)\].

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Dr. Ertugrul Okuyan · Bagcilar Egitim ve Arastirma Hastanesi

  • Dr. Omer Kozan · Siyami Ersek Gogus Kalp ve Damar Cerrahisi Egitim ve Arastirma Hastanesi

  • Dr. Jan - Peter V Kuijk · St. Antonius Hospital

  • Dr. Jakub Podolec · Krakowski Szpital Specjalistyczny im. Jana Pawla II

  • Dr. Andrzej Ochala · Zaklad Kardiologii Inwazyjnej

  • Dr. Oleg Polonetsky · National Scientific and Practical Centre - Cardiology

  • Dr. Orazbek Sakhov · City Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2021-12-01
Completion
2022-06-22

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721614 on ClinicalTrials.gov