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

Bifurcation Coronary Disease Clinical Trial

— ABC  

Official title:

AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00914979
• Other study ID #: 0033 - 08 - EMC
• Status: Terminated
• Phase: Phase 3
• First received: June 4, 2009
• Last updated: June 21, 2015
• Start date: September 2008
• Est. completion date: September 2011

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bifurcation Coronary Disease
• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• AngioSculpt
The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip

Locations

Country	Name	City	State
Israel	Khalid Suleiman	Afula
Israel	Oded Izenberg	Rehovot
Israel	Alexander Goldberg	Zefat
Israel	Ricardo Krakover	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		9 Months	Yes
Secondary	Rate of side branch stenting		9 Months	Yes
Secondary	Angiographic dissection rate and grade		9 months	Yes
Secondary	MACE rate at 30 days post-procedure		9 months	Yes
Secondary	Cumulative stent thrombosis and TLR rates at 9 months		9 months	Yes