Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01612767
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2012-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
BIOHELIX-I Bare Metal Stent Study
Sponsor:
Biotronik, Inc.
Organization:
Study Overview
Official Title:
The Treatment of Coronary Artery Lesions Using the PRO-Kinetic Energy Cobalt-Chromium, Bare-Metal Stent
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOHELIX-I
Brief Summary:
The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: