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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00914979
Recruitment Status : Terminated (Difficulties in recruiting patients)
First Posted : June 5, 2009
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

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

Condition or disease Intervention/treatment Phase
Bifurcation Coronary Disease Device: AngioSculpt Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Rate of side branch stenting [ Time Frame: 9 Months ]
  2. Angiographic dissection rate and grade [ Time Frame: 9 months ]
  3. MACE rate at 30 days post-procedure [ Time Frame: 9 months ]
  4. Cumulative stent thrombosis and TLR rates at 9 months [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00914979

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Khalid Suleiman
Afula, Israel, 18101
Oded Izenberg
Rehovot, Israel
Alexander Goldberg
Zefat, Israel
Ricardo Krakover
Zrifin, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
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Principal Investigator: Khalid Suleiman, MD Heart Institute; Ha'Emek Medical Center
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Responsible Party: HaEmek Medical Center, Israel Identifier: NCT00914979    
Other Study ID Numbers: 0033 - 08 - EMC
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Keywords provided by HaEmek Medical Center, Israel:
Bifurcation Lesion
Side branch
Additional relevant MeSH terms:
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Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases