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

Primary Purpose

Bifurcation Coronary Disease

Status
Terminated
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
AngioSculpt
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bifurcation Coronary Disease focused on measuring Angiosculpt, Bifurcation Lesion, Side branch, IVUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Khalid Suleiman
  • Oded Izenberg
  • Alexander Goldberg
  • Ricardo Krakover

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Single Arm - Interventional

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2009
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00914979
Brief Title
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study)
Acronym
ABC
Official Title
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting patients
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bifurcation Coronary Disease
Keywords
Angiosculpt, Bifurcation Lesion, Side branch, IVUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Single Arm - Interventional
Intervention Type
Device
Intervention Name(s)
AngioSculpt
Intervention Description
The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Rate of side branch stenting
Time Frame
9 Months
Title
Angiographic dissection rate and grade
Time Frame
9 months
Title
MACE rate at 30 days post-procedure
Time Frame
9 months
Title
Cumulative stent thrombosis and TLR rates at 9 months
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Suleiman, MD
Organizational Affiliation
Heart Institute; Ha'Emek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khalid Suleiman
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Oded Izenberg
City
Rehovot
Country
Israel
Facility Name
Alexander Goldberg
City
Zefat
Country
Israel
Facility Name
Ricardo Krakover
City
Zrifin
Country
Israel

12. IPD Sharing Statement

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

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