A Prospective, Single-arm, Multi-centre, Observational, Real World Registry
NCT ID: NCT02901353
Last Updated: 2020-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2017-02-02
2022-12-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Sirolimus Eluting Coronary Stent System
Patient with Angina Pectoris will be enrolled for the intervention
Eligibility Criteria
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Inclusion Criteria
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
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.
\-
18 Years
ALL
No
Sponsors
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Meril Life Sciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc
Role: PRINCIPAL_INVESTIGATOR
University of Semmelweis
Dr. Szűk Tibor, Ph.D, MD
Role: PRINCIPAL_INVESTIGATOR
University of Debrecen
Dr. P. Agostoni, Ph.D, MD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Nieuwegein
Dr. Imad A Haddad, MD
Role: PRINCIPAL_INVESTIGATOR
Jordan Hospital
Dr. Ramesh Singh, MBBS, MRCP
Role: PRINCIPAL_INVESTIGATOR
University Malaya Medical Centre (UMMC)
Locations
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University of Semmelweis
Budapest, Europe, Hungary
University of Debrecen
Debrecen, Europe, Hungary
Jordan Hospital
Amman, , Jordan
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Selangor, Malaysia
St. Antonius Hospital
Nieuwegein, Germany, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Dr. P. Agostoni
Role: primary
Other Identifiers
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BIO/MOR-I
Identifier Type: -
Identifier Source: org_study_id
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