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
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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