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

HaEmek Medical Center, Israel

Status and phase: Terminated; Phase 3

Conditions: Bifurcation Coronary Disease

Treatments: Device: AngioSculpt

Study type: Interventional

Funder types: Other

Identifiers

NCT00914979

0033 - 08 - EMC

Details and patient eligibility

About

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

Full 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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

1

Experimental group

Description:

Single Arm - Interventional

Treatment:

Device: AngioSculpt