AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry

HaEmek Medical Center, Israel4 sites in 1 country7 target enrollmentSeptember 2008

ConditionsBifurcation Coronary Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bifurcation Coronary Disease
Sponsor: HaEmek Medical Center, Israel
Enrollment: 7
Locations: 4
Primary Endpoint: Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

September 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

HaEmek Medical Center, Israel

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).

Exclusion Criteria

•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.