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

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ClinicalTrials.gov Identifier: NCT00914979
Recruitment Status : Terminated (Difficulties in recruiting patients)
First Posted : June 5, 2009
Last Update Posted : June 23, 2015
Sponsor:
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

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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00914979     History of Changes
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:
Angiosculpt
Bifurcation Lesion
Side branch
IVUS

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