Status:
TERMINATED
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Bifurcation Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.
Detailed Description
The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associ...
Eligibility Criteria
Inclusion
- Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).
Exclusion
- Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
- Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00914979
Start Date
September 1 2008
End Date
September 1 2011
Last Update
June 23 2015
Active Locations (4)
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1
Khalid Suleiman
Afula, Israel, 18101
2
Oded Izenberg
Rehovot, Israel
3
Alexander Goldberg
Safed, Israel
4
Ricardo Krakover
Zrifin, Israel