NCT02710656

Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease

Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Cardionovum GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

Detailed description

This interventional study will collect data about the treatment of de novo lesions or restenotic lesions. Restenotic lesions that are previously DCB (drug coated balloon) treated or in-stent restenosis are excluded in this study. The primary objective of this randomized study is to compare the efficacy of the DCB (Legflow - Cardionovum) versus POBA for the treatment of de novo lesions or restenosis in the SFA and in the popliteal artery (segment P1 -P2) by assessing the binary restenosis rate with duplex ultrasonography at 12 months. The secondary endpoints are the assessment of the immediate procedural outcome, distribution of Rutherford, mortality, target lesion revascularization (TLR), target extremity revascularization (TER), amputation and anklebrachial index (ABI). For each patient enrolled, data will be collected up to 12 months after the procedure.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Legflow® balloon	Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel
DEVICE	Standard PTA	Percutaneous angioplasty performed with a standard balloon

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2016-03-17
• Last updated: 2020-01-23

Locations

9 sites across 3 countries: Belgium, France, Germany