Bifurcation Coronary Disease
Conditions
Keywords
Angiosculpt, Bifurcation Lesion, Side branch, IVUS
Brief summary
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.
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
Interventions
DEVICEAngioSculpt
The AngioSculpt Scoring Balloon Catheter is a standard balloon dilatation catheter with a scoring balloon near the distal tip
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of side branch stenting | 9 Months |
| Angiographic dissection rate and grade | 9 months |
| MACE rate at 30 days post-procedure | 9 months |
| Cumulative stent thrombosis and TLR rates at 9 months | 9 months |
Countries
Israel
Outcome results
None listed