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

Angina Pectoris Clinical Trial

— Morpheus  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02901353
• Other study ID #: BIO/MOR-I
• Status: Recruiting
• Start date: February 2, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2020
• Source: Meril Life Sciences Pvt. Ltd.
• Contact: Ashok Thakkar, Ph.D
• Phone: +91 9879443584
• Email: ashok.thakkar[@]merillife.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Angina Pectoris

Intervention

Device:
• Sirolimus Eluting Coronary Stent System
Patient with Angina Pectoris will be enrolled for the intervention

Locations

Country	Name	City	State
Hungary	University of Semmelweis	Budapest	Europe
Hungary	University of Debrecen	Debrecen	Europe
Jordan	Jordan Hospital	Amman
Malaysia	University Malaya Medical Centre (UMMC)	Kuala Lumpur	Selangor
Netherlands	St. Antonius Hospital	Nieuwegein	Germany

Sponsors (1)

Lead Sponsor	Collaborator
Meril Life Sciences Pvt. Ltd.

Countries where clinical trial is conducted

Hungary,  Jordan,  Malaysia,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Device Success	Angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device	Before Discharge
Primary	Freedom of target lesion failure	composite of cardiac death, myocardial infarction and target lesion revascularization.	TLF at 6 month
Primary	Freedom of target lesion failure	composite of cardiac death, myocardial infarction and target lesion revascularization.	TLF upto 24 months
Secondary	MACE	composite of cardiac death, myocardial infarction attributed to the target vessel or Ischemia-driven TLR.	1, 6, 12 and 24 month
Secondary	Target vessel failure	cardiac death, myocardial infarction attributed to the target vessel, or target vessel revascularization.	1, 6, 12 and 24 month
Secondary	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