Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study.

Objectives: This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO).

Background: CTOs are difficult to treat, and the optimal intervention remains to be determined.

Methods: The IN.

Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease.

Background The IN.PACT Global Study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of a drug-coated balloon in the treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries (P1-P3) in subjects with intermittent claudication and/or rest pain. Prespecified subjects were selected for core-laboratory-adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥15 cm).

Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort.

Objectives: This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR).

Background: Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention.