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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901353
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Meril Life Sciences Pvt. Ltd.

Tracking Information
First Submitted Date August 11, 2016
First Posted Date September 15, 2016
Last Update Posted Date February 21, 2020
Actual Study Start Date February 2, 2017
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2020)
  • Freedom of target lesion failure [ Time Frame: TLF at 6 month ]
    composite of cardiac death, myocardial infarction and target lesion revascularization.
  • Freedom of target lesion failure [ Time Frame: TLF upto 24 months ]
    composite of cardiac death, myocardial infarction and target lesion revascularization.
Original Primary Outcome Measures
 (submitted: September 14, 2016)
Freedom of target lesion failure [ Time Frame: TLF at 6 month and up to 24 month ]
Change History
Current Secondary Outcome Measures
 (submitted: February 19, 2020)
  • MACE [ Time Frame: 1, 6, 12 and 24 month ]
    composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR.
  • Target vessel failure [ Time Frame: 1, 6, 12 and 24 month ]
    cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.
  • Academic Research Consortium (ARC) defined stent thrombosis [ Time Frame: 1, 6, 12 and 24 month ]
    Definite, probable and possible stent thrombosis during acute, subacute, late and very late phase.
Original Secondary Outcome Measures
 (submitted: September 14, 2016)
  • MACE [ Time Frame: 1, 6, 12 and 24 month ]
  • Target vessel failure [ Time Frame: 1, 6, 12 and 24 month ]
Current Other Pre-specified Outcome Measures
 (submitted: February 19, 2020)
  • Procedure Success [ Time Frame: Before Discharge ]
    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)
  • Device Success [ Time Frame: Before Discharge ]
    Angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective, Single-arm, Multi-centre, Observational, Real World Registry
Official 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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
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.
Condition Angina Pectoris
Intervention Device: Sirolimus Eluting Coronary Stent System
Patient with Angina Pectoris will be enrolled for the intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 14, 2016)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

    -

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ashok Thakkar, Ph.D +91 9879443584 ashok.thakkar@merillife.com
Contact: Kartik Vyas, M.Sc. +91 9619129010 kartik.vyas@merillife.in
Listed Location Countries Hungary,   Jordan,   Malaysia,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02901353
Other Study ID Numbers BIO/MOR-I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Meril Life Sciences Pvt. Ltd.
Study Sponsor Meril Life Sciences Pvt. Ltd.
Collaborators Not Provided
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)
PRS Account Meril Life Sciences Pvt. Ltd.
Verification Date February 2020