Rationale and Design of the IN.PACT BTK Randomized Pilot Study: A Paclitaxel Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Total Occlusions

Antonio Micari, MD, PhD1;  Jeffrey J. Popma, MD2;  Francesco Liistro, MD3

Original Contribution

Rationale and Design of the IN.PACT BTK Randomized Pilot Study: A Paclitaxel Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Total Occlusions

Antonio Micari, MD, PhD¹; Jeffrey J. Popma, MD²; Francesco Liistro, MD³

Keywords

below the knee

chronic limb-threatening ischemia

Chronic Total Occlusion

Drug-coated balloon

paclitaxel

peripheral artery disease

June 2021

ISSN 2694-3026

Abstract

Objectives. This is a pilot feasibility study and the objective is to evaluate the safety and effectiveness of the investigational device, IN.PACT 014 drug-coated balloon (DCB), compared with standard percutaneous transluminal angioplasty (PTA) in the treatment of patients with chronic limb-threatening ischemia (CLTI) with chronic total occlusions (CTOs) of below-the-knee (BTK) arteries. Methods and Design. The IN.PACT BTK randomized study is a prospective, multicenter, randomized pilot study. Baseline angiography and duplex ultrasonography analyses were performed to confirm that participants met all anatomic and functional eligibility criteria. Successful predilation and strict intraprocedural angiographic and duplex sonographic criteria were conditions of enrollment and randomization. A total of 50 participants were enrolled and randomized 1:1 into DCB (n = 23) or control PTA (n = 27) treatment groups. The primary effectiveness endpoint is late lumen loss at 9 months post procedure. Secondary endpoints include a composite safety endpoint (freedom from device- and procedure-related mortality within 30 days, and freedom from major target-limb amputation and freedom from clinically driven target-lesion revascularization within 9 months after the procedure) and the rate of major adverse events. Participants are being followed through 5 years. All angiographic and duplex ultrasonography images are reviewed by independent core laboratories and all major adverse events are adjudicated by an independent clinical events committee. Discussion and Conclusion. This is a rigorously designed BTK trial in which participant selection and enrollment were a unique aspect, guided by a strict requirement for successful vessel preparation before randomization using explicit angiographic and duplex ultrasound parameters.

J CRIT LIMB ISCHEM 2021;1(2):E35-E44.

Key words: below the knee, chronic limb-threatening ischemia, chronic total occlusion, drug-coated balloon, paclitaxel,
peripheral artery disease

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Affiliations and Disclosures