NCT02901353

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
4 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

3.8 years

First QC Date

August 11, 2016

Last Update Submit

February 19, 2020

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (2)

  • Freedom of target lesion failure

    composite of cardiac death, myocardial infarction and target lesion revascularization.

    TLF at 6 month

  • Freedom of target lesion failure

    composite of cardiac death, myocardial infarction and target lesion revascularization.

    TLF upto 24 months

Secondary Outcomes (3)

  • MACE

    1, 6, 12 and 24 month

  • Target vessel failure

    1, 6, 12 and 24 month

  • Academic Research Consortium (ARC) defined stent thrombosis

    1, 6, 12 and 24 month

Other Outcomes (2)

  • Procedure Success

    Before Discharge

  • Device Success

    Before Discharge

Interventions

Sirolimus Eluting Coronary Stent SystemDEVICE

Patient with Angina Pectoris will be enrolled for the intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • The patient must be at least 18 years of age.
  • Significant native coronary artery stenosis (\> 50% by visual estimate) with lesion length of ≤56mm.
  • 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 -

You may not qualify if:

  • Patients contraindicated to any of the following medications: aspirin, heparin, clopidogrel, cobalt-chromium, contrast agents and sirolimus.
  • An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrolment.
  • Patients who are actively participating in another drug or device investigational study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Semmelweis

Budapest, Europe, 1085, Hungary

RECRUITING

University of Debrecen

Debrecen, Europe, 4032, Hungary

RECRUITING

Jordan Hospital

Amman, Jordan

RECRUITING

University Malaya Medical Centre (UMMC)

Kuala Lumpur, Selangor, 59100, Malaysia

RECRUITING

St. Antonius Hospital

Nieuwegein, Germany, 3435CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof. Dr. Bela Merkely, MD, Ph.D, D.Sc

    University of Semmelweis

    PRINCIPAL INVESTIGATOR

  • Dr. Szűk Tibor, Ph.D, MD

    University of Debrecen

    PRINCIPAL INVESTIGATOR

  • Dr. P. Agostoni, Ph.D, MD

    St. Antonius Nieuwegein

    PRINCIPAL INVESTIGATOR

  • Dr. Imad A Haddad, MD

    Jordan Hospital

    PRINCIPAL INVESTIGATOR

  • Dr. Ramesh Singh, MBBS, MRCP

    University Malaya Medical Centre (UMMC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashok Thakkar, Ph.D

CONTACT

+91 9879443584ashok.thakkar@merillife.com

Kartik Vyas, M.Sc.

CONTACT

+91 9619129010kartik.vyas@merillife.in

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

September 15, 2016

Study Start

February 2, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2022

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)HU(2)MY(1)JO(1)