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

  • STATUS
    Not Recruiting
  • participants needed
    130
  • sponsor
    Cardionovum GmbH
Updated on 15 June 2021
angiography
stenosis

Summary

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

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.

Details
Condition Atherosclerosis
Treatment standard PTA, Legflow® balloon
Clinical Study IdentifierNCT02710656
SponsorCardionovum GmbH
Last Modified on15 June 2021

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