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Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease

NCT05651165 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-12-14

No results posted yet for this study

Summary

More advanced and severe cases of chronic lower limb ischemia (the so-called critical lower limb ischemia) are painful and limiting conditions that impact on patients' quality of life.

Until now, the available evidence for the femoropopliteal area only defines open surgery or endovascular treatment indications. However, the best strategy for endovascular procedures is still unclear. The popliteal artery is a challenging anatomical site for balloon angioplasty alone and standard nitinol stenting angioplasty.

This randomized clinical trial aims to assess the superiority of nitinol stent angioplasty compared to pharmacoactive balloon angioplasty to treat critical lower limb ischemia due to popliteal artery arteriosclerosis.

Conditions

  • Popliteal Arterial Stenosis

Interventions

DEVICE

Pharmacoactive balloon angioplasty. Lutonix®

Percutaneous transluminal angioplasty with paclitaxel-coated balloon in the arteriosclerosis site to increase blood-flow to the distal arterial areas.

DEVICE

Mimetic stent.Supera®

Multiple intertwined nitinol wires that provide greater radial resistance and allow for even stress distribution. Implanted through percutaneous transluminal angioplasty in the arteriosclerosis site to increase blood-flow to the distal arterial areas.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Principal Investigators

  • Xavier M Mestre, MD · Vascular Surgeon Hospital Universitari de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651165 on ClinicalTrials.gov