AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)

Phase 3

Terminated

• Conditions: Bifurcation Coronary Disease
• Interventions: Device: AngioSculpt

• Registration Number: NCT00914979
• Lead Sponsor: HaEmek Medical Center, Israel

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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AngioSculpt	Single Arm - Interventional

Primary Outcome Measures

Name	Time	Method
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	9 Months

Secondary Outcome Measures

Name	Time	Method
Rate of side branch stenting	9 Months
Angiographic dissection rate and grade	9 months
MACE rate at 30 days post-procedure	9 months
Cumulative stent thrombosis and TLR rates at 9 months	9 months

Trial Locations

Locations (4)

Khalid Suleiman; 🇮🇱 Afula, Israel

Oded Izenberg; 🇮🇱 Rehovot, Israel

Alexander Goldberg; 🇮🇱 Zefat, Israel

Ricardo Krakover; 🇮🇱 Zrifin, Israel