A Prospective, Single-arm, Multi-centre, Observational, Real World Registry

• Conditions: Angina Pectoris

• Registration Number: NCT02901353
• Lead Sponsor: Meril Life Sciences Pvt. Ltd.

Brief Summary

A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.

Detailed Description

Title:

A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.

Short Title:

Morpheus - Global Registry Sponsor: Meril Life Sciences Pvt. Ltd

Device Used:BioMime™ Morph Sirolimus Eluting Coronary Stent System

Study population:

The utilization of the BioMime™ Morph Sirolimus Eluting Coronary Stent System implantation in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.

Enrolment:Minimum 400 patients will be enrolled

Clinical Sites:Minimum 15 sites

Objectives:Purpose of this Registry is to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System in very long (length ≤ 56 mm) coronary lesions in native coronary arteries with reference vessel diameter of 2.25 mm to 3.50 mm.

Study Design:This is a prospective, single-arm, multi-centre, observational, real world registry. All patients will be followed for up to 24 months.

Primary Outcome Measures:Freedom of target lesion failure (TLF) at 6 month and up to 24 month TLF is defined as a composite of cardiac death, myocardial infarction and target lesion revascularization.

Secondary Outcome Measures:

1. MACE at 1, 6, 12 and 24 month Defined as a composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR .

2. Target vessel failure at 1, 6, 12 and 24 month Defined as cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.

3. Academic Research Consortium (ARC) defined stent thrombosis at 1, 6, 12 and 24 months.

Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase.

Other Outcome Measures:

1. Procedure Success:

It is defined as angiographic evidence of \<30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MACE prior to hospital discharge (for subjects with more than one lesion stented, the worse case is counted)

2. Device Success:

It is defined as angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-15
• Study Start: 2017-02-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21
• Primary Completion: 2020-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. The patient must be at least 18 years of age.
2. Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of ≤56mm.
3. The patient or guardian agrees to the protocol requirements and the schedule of follow-up and provides informed written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site -

Exclusion Criteria

1. Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus.

2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment.

3. Patients who are actively participating in another drug or device investigational study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom of target lesion failure	TLF upto 24 months	composite of cardiac death, myocardial infarction and target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Academic Research Consortium (ARC) defined stent thrombosis	1, 6, 12 and 24 month	Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase.
MACE	1, 6, 12 and 24 month	composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR.
Target vessel failure	1, 6, 12 and 24 month	cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.

Trial Locations

Locations (5)

University Malaya Medical Centre (UMMC); 🇲🇾 Kuala Lumpur, Selangor, Malaysia

University of Semmelweis; 🇭🇺 Budapest, Europe, Hungary

University of Debrecen; 🇭🇺 Debrecen, Europe, Hungary

Jordan Hospital; 🇯🇴 Amman, Jordan

St. Antonius Hospital; 🇳🇱 Nieuwegein, Germany, Netherlands