Status:
WITHDRAWN
Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
Lead Sponsor:
Kantonsspital Aarau
Conditions:
Peripheral Arterial Disease
Popliteal Artery Stenosis
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
The femoro-popliteal (FP) artery is the most frequently treated vascular segment in patients with symptomatic peripheral artery disease (PAD), for which endovascular therapy became an established trea...
Detailed Description
Randomized trial to investigate the impact of different stent designs on the target lesion restenosis rate in femoro-popliteal arteries. Immediately after stent implantation, sets of three orthogonal ...
Eligibility Criteria
Inclusion
- Written informed consent prior to any study procedure,
- Presence of PAD (2 - 3 Rutherford-Becker class),
- Atherosclerotic de-novo lesion (stenosis \>70% or occlusion) of the distal part of the superficial femoral artery and/or any part of the popliteal artery,
- Target lesion-length: 4cm to 12cm,
- Target vessel diameter: 5mm to 7mm,
- Guidewire must cross target lesion and located intraluminally before randomization,
- At least one (1) patent below-the knee artery (=with no stenosis \>50%),
- Possibility to treat the target lesion with one (1) study stent
- Interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure, are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful.
Exclusion
- Pregnancy,
- Angiographic evidence of thrombus within the target lesion,
- Patients with acute critical limb ischemia (Rutherford-Becker class 4-6),
- Restenosis of the target lesion,
- Non-atherosclerotic obstructions of the target lesion,
- Aneurysm of the target lesion,
- Renal failure, defined as GFR, \<40 mL/min/1.73m2,
- Patient's inability to follow the study procedures e.g. psychological disorders, dementia, etc.,
- Previous enrolment into an ongoing study,
- Known or suspected allergies or contraindications to aspirin and/or clopidogrel, heparin,
- Coagulation disorders, or general refusal of the patient to receive blood transfusions,
- Contrast allergy that cannot be treated,
- Thrombolysis therapy including 72 hours before the planned index procedure,
- Myocardial infarction or stroke \<30 days prior to index procedure.
- Equipment is unavailable to fulfill study treatments.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04700371
Start Date
December 1 2023
End Date
August 1 2024
Last Update
March 12 2024
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