Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease
NCT ID: NCT05651165
Last Updated: 2022-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2021-12-01
2024-01-31
Brief Summary
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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.
Detailed Description
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Critical lower limb ischemia usually benefits from revascularization and requires cautious surgical planning with complementary imaging tests able to locate the lesion site precisely. In our setting, the most used test is arterial cartography with doppler ultrasound. Afterward, surgeons should decide whether to perform open surgery or endovascular treatment.
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. Given its anatomy, the popliteal artery undergoes many flexion-extension and rotational movements, making it a challenging site for balloon angioplasty alone (high incidence of restenosis) and standard nitinol stenting angioplasty (risk of stent fractures).
Mimetic stents have been developed to overcome the risk of stent fractures. They consist of multiple intertwined nitinol wires that provide greater radial resistance and allow for even stress distribution.
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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Patients receiving pharmacoactive balloon angioplasty. Lutonix®
Pharmacoactive balloon angioplasty. Lutonix®
Percutaneous transluminal angioplasty with paclitaxel-coated balloon in the arteriosclerosis site to increase blood-flow to the distal arterial areas.
Group B
Patients receiving mimetic stent. Supera®
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.
Interventions
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Pharmacoactive balloon angioplasty. Lutonix®
Percutaneous transluminal angioplasty with paclitaxel-coated balloon in the arteriosclerosis site to increase blood-flow to the distal arterial areas.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients admitted to the Vascular Surgery Department of the Bellvitge Hospital University to treat critical lower limb ischemia for endovascular treatment.
3. With involvement of the Popliteal artery in-between the Hunter's canal and the start of the tibial artery branch.
4. WOCBP must use highly effective methods of contraception.
5. Patients who sign the written informed consent.
Exclusion Criteria
2. Patients requiring amputation.
3. Patients who underwent previous revascularization of the same limb (same artery).
4. The main involvement is from an arterial territory other than the popliteal artery.
5. Pregnant women.
6. Inability of overcoming the arterial lesion during the endovascular procedure.
7. Affected artery's diameter \<4 mm.
18 Years
80 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Carlos Martínez Rico
Vascular Surgeon
Principal Investigators
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Xavier M Mestre, MD
Role: PRINCIPAL_INVESTIGATOR
Vascular Surgeon Hospital Universitari de Bellvitge
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Carlos M Rico, MD
Role: primary
Malka Huici, MD
Role: backup
Other Identifiers
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ACV-MIM-2020-01
Identifier Type: -
Identifier Source: org_study_id