Premium
A prospective, multi‐center study of the chocolate balloon in femoropopliteal peripheral artery disease: The C hocolate BAR registry
Author(s) -
Mustapha Jihad A.,
Lansky Alexandra,
Shishehbor Mehdi,
Miles McClure John,
Johnson Sarah,
Davis Thomas,
Makam Prakash,
Crowder William,
Konstantino Eitan,
Attaran Robert R.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27565
Subject(s) - medicine , surgery , clinical endpoint , stenosis , population , balloon , percutaneous , amputation , radiology , angioplasty , randomized controlled trial , environmental health
The Chocolate BAR study is a prospective multicenter post‐market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow‐limiting dissection); secondary long‐term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12‐months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all‐cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an “all‐comers” population achieved excellent procedural outcomes with low dissection rates and bailout stent use.