Morpheus Global Registry

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.

ClinicalTrials.gov Identifier: NCT02901353

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.