A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
J A MustaphaChocolate Bar Investigators

Abstract

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.

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Citations

Jun 18, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Ehrin J ArmstrongPeter A Schneider
Jun 1, 2019·Expert Review of Medical Devices·Stavros SpiliopoulosElias Brountzos
Dec 26, 2018·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Andrew HoldenMarianne Brodmann
Jun 27, 2019·The Journal of Cardiovascular Surgery·Michel Bosiers
May 21, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Thomas ZellerJohn P Pigott
Mar 10, 2020·F1000Research·Andrew Lazar, Nicholas Morrissey
Nov 28, 2020·CVIR Endovascular·William OrmistonAndrew Holden
Nov 12, 2020·Frontiers in Cardiovascular Medicine·François SaucyRafael Trunfio

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