NCT02963649

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Randomized Study of IN.PACT 014 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter vs. Optimal Percutaneous Transluminal Angioplasty for the Treatment of Chronic Total Occlusions in the Infrapopliteal Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.

Conditions

• Critical Limb Ischemia
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	DCB	Drug Coated Balloon
DEVICE	PTA	Percutaneous Transluminal Angioplasty

Timeline

• Start date: 2017-03-02
• Primary completion: 2019-10-07
• Completion: 2023-12-21
• First posted: 2016-11-15
• Last updated: 2025-07-08
• Results posted: 2025-07-08

Locations

9 sites across 5 countries: Belgium, France, Greece, Italy, Switzerland