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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-09-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Bifurcation Coronary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Single Arm - Interventional

Group Type EXPERIMENTAL

AngioSculpt

Intervention Type DEVICE

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

Interventions

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AngioSculpt

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No