To evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.

Morph-India: A prospective, single-arm, multi-centre, observational, real world, post-marketing surveillance to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions. - Morph-India

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/12/007527

Enrollment

400

Registered

2016-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Intervention1: BioMime Morph: Sirolimus Eluting Coronary Stent System Control Intervention1: NIL: NIL

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Freedom of target lesion failure (TLF) at 6 month and up to 24 months TLF is defined as a composite of cardiac death, myocardial infarction and target lesion revascularizationTimepoint: Freedom of target lesion failure (TLF) at 6 month and up to 24 months TLF is defined as a composite of cardiac death, myocardial infarction and target lesion revascularization	—

Secondary

Measure	Time frame
1.MACE at 1,6,12 and 24MOS 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 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.Timepoint: 1, 6, 12 and 24 month	—

Measure

Time frame

1.MACE at 1,6,12 and 24MOS 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 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.Timepoint: 1, 6, 12 and 24 month

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Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt. Ltd

ashok.thakkar@merillife.com912603052100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026