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

Atherosclerosis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02710656
Study type Interventional
Source Cardionovum GmbH
Contact
Status Completed
Phase N/A
Start date March 2016
Completion date November 2019
View Details
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