Evaluation of Luminal Expansion Following Stenting of Femoro-popliteal Occlusive Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary goal of this trial is to compare prospectively stent opening of Supera (IDEV Technologies) versus a reference stent (LifeStent, Bard Medical) using C-arm CT. A secondary goal is to correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iliac, Common and External (ICE) Artery Stent Trial

NCT01305174

Vascular Lesions

TERMINATED PHASE4

Endovascular Treatment of Peripheral Artery Disease

NCT03346577

Peripheral Arterial Disease Iliac Artery Disease Below-the-knee Obstruction +1 more

TERMINATED

A Study Evaluating the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy

NCT04349657

Peripheral Arterial Disease

RECRUITING NA

Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

NCT06112171

Peripheral Arterial Disease

RECRUITING NA

Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)

NCT00906022

Patients With Symptomatic Critical Limb Ischemia Severe Intermittent Claudication

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Femoropopliteal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supera stent

The Supera stent is a novel interwoven nitinol stent design with high flexibility and radial strength. The radial force of the Supera stent is 4 times higher than comparable nitinol stent.

Group Type ACTIVE_COMPARATOR

Supera Stent

Intervention Type DEVICE

Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).

LifeStent

LifeStent is likely the best reference nitinol stent for comparison because a low restenosis rate has been reported at 1 year with low target revascularization.

Group Type ACTIVE_COMPARATOR

Life Stent

Intervention Type DEVICE

Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supera Stent

Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).

Intervention Type DEVICE

Life Stent

Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years
* Patient (or legally authorized representative) must give a written informed consent.
* Symptomatic peripheral-artery disease with moderate or severe intermittent claudication and failure of medical treatment (Rutherford stage 2,3) or chronic critical limb ischemia with pain while the patient is at rest (Rutherford stage 4) or chronic critical limb ischemia with ischemic ulcers (Rutherford stage 5, 6) and stenosis of more than 70 percent or occlusion of the ipsilateral superficial femoral artery and/or proximal popliteal artery with a target-lesion length of ≥ 8 and ≤ 20 cm and at least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel (TASC A,B,C lesions)25. Proximal popliteal artery is defined as the popliteal artery above the joint line. The distal portion of the lesion should be located at least 4 cm above the joint line and the distal end of the stent 2 cm above the joint line.
* ABI ≤ 0.9 at rest. Toe-Brachial Index (TBI) may be used if ABI is inadequate.
* Lesion with a calcification percentage of at least 25% based on CTA evaluation (within 6 months of patient enrolment)

Exclusion Criteria

* Acute critical limb ischemia
* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion).
* Renal failure, creatinine clearance \< 50 µmol /l
* Severe allergy to iodine contrast
* Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
* Lesions \< 8 and \> 20 cm in length
* Calcification volume of less than 25%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No