Clinical trial NCT02901353: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Angina Pectoris
Lead sponsor: Meril Life Sciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

   -

Primary outcomes:
measure: Freedom of target lesion failure
timeFrame: TLF at 6 month
measure: Freedom of target lesion failure
timeFrame: TLF upto 24 months
Secondary outcomes:
measure: MACE
timeFrame: 1, 6, 12 and 24 month
measure: Target vessel failure
timeFrame: 1, 6, 12 and 24 month
measure: Academic Research Consortium (ARC) defined stent thrombosis
timeFrame: 1, 6, 12 and 24 month
Other outcomes:
measure: Procedure Success
timeFrame: Before Discharge
measure: Device Success
timeFrame: Before Discharge
Locations:
city: Budapest
country: Hungary
facility: University of Semmelweis
state: Europe
city: Debrecen
country: Hungary
facility: University of Debrecen
state: Europe
city: Amman
country: Jordan
facility: Jordan Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre (UMMC)
state: Selangor
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
state: Germany
Study officials:
affiliation: University of Semmelweis
name: Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Debrecen
name: Dr. Szűk Tibor, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Nieuwegein
name: Dr. P. Agostoni, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jordan Hospital
name: Dr. Imad A Haddad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Malaya Medical Centre (UMMC)
name: Dr. Ramesh Singh, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
References: