BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions

Coronary Artery Disease Clinical Trial

Official title:

BIOTRONIK-Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in the Treatment of Patients With Single de Novo Coronary Artery Lesions in an Indian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426139
• Other study ID #: C1002
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: April 3, 2013
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Main Inclusion Criteria:

• Subject has provided a written informed consent

• Single de novo lesion with = 50% and <100% stenosis in up to 2 coronary arteries

• The target lesion length is = 26 mm

• The target reference vessel diameter is = 2.0 mm and = 4.0 mm

Main Exclusion Criteria:

• Evidence of myocardial infarction within 72 hours prior to index procedure

• Unprotected left main coronary artery disease (stenosis >50%)

• Three-vessel coronary artery disease at time of procedure Thrombus in target vessel

• Target lesion involves a side branch > 2.0 mm in diameter

• Heavily calcified lesion

• Target lesion is located in or supplied by an arterial or venous bypass graft

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous Coronary Intervention Biotronik Orsiro DES
Stenting

Locations

Country	Name	City	State
India	Madras Medical Mission	Chennai
India	Medanta The Medicity Hospital	Gurgaon
India	Fortis Escorts Heart Institute and Research Centre	New Delhi
India	Max Super Speciality Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Stent Late Lumen Loss		9 months post index procedure	No