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

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

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

Study Overview

• Status: Terminated
• Conditions: Bifurcation Coronary Disease
• Intervention / Treatment: Device: AngioSculpt

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • Khalid Suleiman
  • Rehovot, Israel
    • Oded Izenberg
  • Zefat, Israel
    • Alexander Goldberg
  • Zrifin, Israel
    • Ricardo Krakover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Single Arm - Interventional	Device: AngioSculpt; The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Khalid Suleiman, MD, Heart Institute; Ha'Emek Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 4, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimate): June 5, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 21, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: IVUS; Angiosculpt; Bifurcation Lesion; Side branch
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: 0033 - 08 - EMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No