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

This study has been terminated.
(Difficulties in recruiting patients)
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00914979
First received: June 4, 2009
Last updated: June 21, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Bifurcation Coronary Disease
Device: AngioSculpt
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry

Further study details as provided by HaEmek Medical Center, Israel:

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 [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of side branch stenting [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
  • Angiographic dissection rate and grade [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • MACE rate at 30 days post-procedure [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Cumulative stent thrombosis and TLR rates at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: September 2008
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914979

Locations
Israel
Khalid Suleiman
Afula, Israel, 18101
Oded Izenberg
Rehovot, Israel
Alexander Goldberg
Zefat, Israel
Ricardo Krakover
Zrifin, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Khalid Suleiman, MD Heart Institute; Ha'Emek Medical Center
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00914979     History of Changes
Other Study ID Numbers: 0033 - 08 - EMC
Study First Received: June 4, 2009
Last Updated: June 21, 2015
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Angiosculpt
Bifurcation Lesion
Side branch
IVUS

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 01, 2015