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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Angina Pectoris
• Intervention / Treatment: Device: Sirolimus Eluting Coronary Stent System

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Hungary
  • Europe
    • Budapest, Europe, Hungary, 1085
      • Recruiting
      • University of Semmelweis
      • Contact: Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc; Email: Merkely.Bela@kardio.sote.hu
    • Debrecen, Europe, Hungary, 4032
      • Recruiting
      • University of Debrecen
      • Contact: Dr. Szűk Tibor, Ph.D, MD; Email: tszuk01@gmail.com
• Jordan
  • Amman, Jordan
    • Recruiting
    • Jordan Hospital
    • Contact: Dr. Imad A Haddad, MD; Email: alhaddad63@gmail.com
• Malaysia
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 59100
      • Recruiting
      • University Malaya Medical Centre (UMMC)
      • Contact: Dr. Ramesh Singh, MBBS, MRCP; Email: ramesh@ummc.edu.my
• Netherlands
  • Germany
    • Nieuwegein, Germany, Netherlands, 3435CM
      • Recruiting
      • St. Antonius Hospital
      • Contact: Dr. P. Agostoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom of target lesion failure	composite of cardiac death, myocardial infarction and target lesion revascularization.	TLF at 6 month
Freedom of target lesion failure	composite of cardiac death, myocardial infarction and target lesion revascularization.	TLF upto 24 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	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)	Before Discharge
Device Success	Angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device	Before Discharge

Collaborators and Investigators

• Sponsor: Meril Life Sciences Pvt. Ltd.
• Investigators: Principal Investigator: Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc, University of Semmelweis; Principal Investigator: Dr. Szűk Tibor, Ph.D, MD, University of Debrecen; Principal Investigator: Dr. P. Agostoni, Ph.D, MD, St. Antonius Nieuwegein; Principal Investigator: Dr. Imad A Haddad, MD, Jordan Hospital; Principal Investigator: Dr. Ramesh Singh, MBBS, MRCP, University Malaya Medical Centre (UMMC)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: BIO/MOR-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No