Vessel Deformations and Restenosis After Stenting of the Popliteal Artery

NCT04700371 | Withdrawn DMC

• 1 other identifier: 1.0-2020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 treatment option during the last decades. However, loss of primary patency and consecutive clinically driven target lesion revascularization (TLR) limit this procedure. Moreover, in the popliteal artery (PA), evidence about the best treatment strategy to prevent loss of patency and TLR is limited to only a few randomized controlled trials (RCT). Arterial deformations of the PA with its unique anatomical properties during leg flexion might explain the poor technical and clinical outcomes in this segment. Generally, a "leave nothing behind" strategy in the PA is preferred, but cannot be avoided in all cases due to e.g. flow limiting dissections or re-coil after balloon angioplasty. Basically two different self-expandable nitinol-based stent designs are available on the market. An interwoven nitinol and laser-cut nitinol stent. The interwoven nitinol stent has a higher radial force in comparison to the laser-cut stent and reveals higher patency rates in the FP arteries. However, a head-to-head comparison of these stents is missing and it remains unknown in which way different stent designs affect the deformation and hemodynamic behaviors of the PA during knee flexion.

Conditions

Peripheral Arterial Disease; Popliteal Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Primary patency

  Primary patency of the target lesion measured by duplex ultrasound

  1 year post index procedure

Secondary Outcomes (1)

• Changes in arterial flow within the target lesion

  6 weeks, 6 months, and 1 year post index procedure

Study Arms (2)

Interwoven stent

ACTIVE COMPARATOR

Use of an interwoven nitinol stent to treat patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.

Device: Interwoven stent

Laser-cut stent

ACTIVE COMPARATOR

Use of a laser-cut nitinol stent to treat patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.

Device: Laser-cut stent

Interventions

Interwoven stent DEVICE

Interwoven nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.

Interwoven stent

Laser-cut stent DEVICE

Laser-cut nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.

Laser-cut stent

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kantonsspital Aarau: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Aljoscha Rastan

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endovascular Therapy, Angiology, Kantonsspital Aarau

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: December 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share