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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00914979
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (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

Contacts
Contact: Khalid Suleiman, MD 972-54-4242999 Suleiman_kh@clalit.org.il
Contact: Limor Ilan- Bushari, MD 972-50-2000741 limor_il@clalit.org.il

Locations
Israel
Khalid Suleiman Recruiting
Afula, Israel, 18101
Contact: Khalid Suleiman, MD    972-54-5242999    Suleiman_kh@clalit.org.il   
Sub-Investigator: Limor Ilan- Bushari, MD         
Sub-Investigator: Yoav Turgeman, MD         
Sub-Investigator: Alexander Feldman, MD         
Oded Izenberg Not yet recruiting
Rehovot, Israel
Contact: Oded Izenberg, MD         
Principal Investigator: Oded IZENBERG, MD         
Alexander Goldberg Not yet recruiting
Zefat, Israel
Contact: Alexander Goldberg, MD    972-50-8434266      
Principal Investigator: Alexander Goldberg, MD         
Ricardo Krakover Not yet recruiting
Zrifin, Israel
Contact: Ricardo Krakover, MD         
Principal Investigator: Ricardo Krakover, MD         
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: Dr. Khalid Suleiman, Heart Institute , Ha'Emek Medical Center
ClinicalTrials.gov Identifier: NCT00914979     History of Changes
Other Study ID Numbers: 0033 - 08 - EMC
Study First Received: June 4, 2009
Last Updated: June 4, 2009
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 Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 22, 2014