Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions

NCT01507519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-04-05

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Sirolimus Eluting Coronary Stent System (Biomime)

Coronary Artey PTCA

Sponsors & Collaborators

  • Lifecare Institute of Medical Sciences and Research Ahmedabad Gujarat India

    collaborator UNKNOWN
  • Meril Life Sciences Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • SAMEER DANI, MD;DM(Card.) · Life Care Institute of Medical Sciences & Research Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-10-31
Completion
2011-03-31

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507519 on ClinicalTrials.gov