NCT01507519

Brief Summary

1.) Indigenously developed and designed BioMimeTM is a

  • predictably safe \& efficacious 3rd generation drug eluting stent (DES)
  • with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut thickness Co-Cr stent,
  • highly documented drug Sirolimus \&
  • a biocompatible, biodegradable polymer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

January 6, 2012

Last Update Submit

April 3, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • MACE at 30 days clinical F/U

    Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).

    30 days

Secondary Outcomes (1)

  • Angiographic Binary restenosis at 8-months F/U

    8-months post implant

Study Arms (1)

BioMime™

EXPERIMENTAL

BioMime™ DES

Device: Sirolimus Eluting Coronary Stent System (Biomime)

Interventions

Sirolimus Eluting Coronary Stent System (Biomime)DEVICE

Coronary Artey PTCA

Also known as: Biomime Sirolimus Eluting Stent System
BioMime™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with \> 18 years of age;
  • Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
  • Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
  • Acceptable candidate for coronary artery bypass graft (CABG) surgery;
  • The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups, including angiographic (and IVUS) follow-ups at 8 months.
  • Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by visual estimation)
  • Target lesions ≤ 19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length);
  • ≥ 50% and \< 100% diameter stenosis;
  • TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2.

You may not qualify if:

  • Known hypersensitivity or contraindication to mTOR inhibitor class drugs (sirolimus), heparin, any required medications including thienopyridines, cobalt chromium, and contrast media which cannot be adequately pre medicated;
  • Patient is a female with childbearing potential;
  • Pre-treatment of the target lesion with any devices other than balloon angioplasty;
  • Previous brachytherapy in the target vessel;
  • Presence of non-target vessel lesions which require staged procedure(s) \< 30 days of the index procedure;
  • Prior CABG surgery to target vessel;
  • Previous percutaneous coronary intervention (PCI) or CABG surgery \< 30 days to the index procedure date;
  • Acute myocardial infarction \< 3 days, with cardiac enzyme elevation including total creatine kinase (CK) \> 2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours;
  • CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure;
  • Documented left ventricular ejection fraction \< 30%;
  • Renal insufficiency determined by a baseline serum creatinine \> 2.0/dl;
  • Thrombocytopenia with a baseline platelet count \< 100,000 cells/mm3;
  • Anemia with baseline hemoglobin \< 10g/dL;
  • Extensive peripheral vascular disease or extreme anticoagulation that precludes safe \> 5 French sheath insertion;
  • History of bleeding diathesis, coagulopathy, or will refuse blood transfusions;
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life Care Institute of Medical Sciences & Research

Ahmedabad, Gujarat, 380024, India

Location

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • SAMEER DANI, MD;DM(Card.)

    Life Care Institute of Medical Sciences & Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: BioMime™ Sirolimus-Eluting Coronary Stent System
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 11, 2012

Study Start

April 1, 2009

Primary Completion

October 1, 2010

Study Completion

March 1, 2011

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

IN(1)