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

Phase 3TerminatedNCT00914979

HaEmek Medical Center, Israel7 enrolled

Overview

Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bifurcation Coronary Disease

Interventions

AngioSculptDEVICE

The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Khalid Suleiman

Afula, Israel

Oded Izenberg

Rehovot, Israel

Alexander Goldberg

Safed, Israel

Ricardo Krakover

Zrifin, Israel

Outcomes

Primary Outcomes

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

Time frame: 9 Months

Secondary Outcomes

Rate of side branch stenting

Time frame: 9 Months

Angiographic dissection rate and grade

Time frame: 9 months

MACE rate at 30 days post-procedure

Time frame: 9 months

Cumulative stent thrombosis and TLR rates at 9 months

Time frame: 9 months

Data from ClinicalTrials.gov

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