Peripheral Arterial DiseaseFIRESTEPNCT04700371
Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
A study testing Interwoven stent and Laser-cut stent in people with Peripheral Arterial Disease and Popliteal Artery Stenosis, run by Kantonsspital Aarau.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease, Popliteal Artery Stenosis
- What is being tested?
- Interwoven stent and Laser-cut stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
About this study
Official title: Flexion-Induced Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
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.
Read the 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 angiographic views (separated by an angle of > 25°) of the stented region (TL) will be obtained with the leg in supine position. This will be followed by intra-arterial imaging using Optical Coherence Tomography (OCT). OCT images (one pullback if the lesion length is < 75 mm, 2 pullbacks otherwise) of the TL will be acquired using the Dragonfly catheter. In addition, duplex ultrasound (DU) of the TL will be performed, including the arterial segments 10cm at proximal and distal edge of the TL. Thereafter, a bending cast will be used to obtain a knee/hip flexion of approximately 70°/20°. In this position the angiographic, OCT, and DU measurements will be repeated.
The OCT images will provide the shapes of the arterial lumen which will be used to generate 3D surface models (in .stl format). The X-ray images will be utilized to construct the 3D arterial centerline for the supine and flexed leg positions. These arterial centerlines will be used to quantify the axial deformation (in mm), twisting (in °), and curvature changes (in mm-1) along the length of the investigated segment. Additionally, the lumen profiles obtained from OCT images will be used to accurately estimate the radial deformations (in mm) in the lumen and define instances of arterial pinching during leg flexion (as the difference in lumen diameters between straight and flexed leg positions).
The geometries of the arterial lumens will be combined with their corresponding 3D arterial centerlines to generate patient-specific arterial models. Along with patient-specific boundary conditions obtained from DU measurements, these models will be transferred to a commercial software, to perform Computational Fluid Dynamics analyses. The changes in these parameters due to leg flexion, as well as due to different stent designs, will be quantified.
- Being tested
- Interwoven stent, Laser-cut stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interwoven stentDevice
Interwoven nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.
Laser-cut stentDevice
Laser-cut nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Laser-cut stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency of the target lesion measured by duplex ultrasound
Measured: 1 year post index procedure
Secondary outcomes (1)
Changes in arterial flow within the target lesion
Changes in blood flow/hemodynamics caused by the different stent designs measured by Computational Fluid Dynamics
Measured: 6 weeks, 6 months, and 1 year post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Dec 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Why it stopped: Lack of financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aljoscha Rastan, MD, Kantonsspital Aarau
- Investigators
- Aljoscha Rastan, Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700371
- Sponsor's protocol ID
- 1.0-2020
- Acronym
- FIRESTEP
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexion-Induced Vessel Deformations and Restenosis After Stenting of the Popliteal Artery
- ClinicalTrials.gov ID
- NCT04700371
- Acronym / sponsor ID
- FIRESTEP / 1.0-2020
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 angiographic views (separated by an angle of > 25°) of the stented region (TL) will be obtained with the leg in supine position. This will be followed by intra-arterial imaging using Optical Coherence Tomography (OCT). OCT images (one pullback if the lesion length is < 75 mm, 2 pullbacks otherwise) of the TL will be acquired using the Dragonfly catheter. In addition, duplex ultrasound (DU) of the TL will be performed, including the arterial segments 10cm at proximal and distal edge of the TL. Thereafter, a bending cast will be used to obtain a knee/hip flexion of approximately 70°/20°. In this position the angiographic, OCT, and DU measurements will be repeated.
The OCT images will provide the shapes of the arterial lumen which will be used to generate 3D surface models (in .stl format). The X-ray images will be utilized to construct the 3D arterial centerline for the supine and flexed leg positions. These arterial centerlines will be used to quantify the axial deformation (in mm), twisting (in °), and curvature changes (in mm-1) along the length of the investigated segment. Additionally, the lumen profiles obtained from OCT images will be used to accurately estimate the radial deformations (in mm) in the lumen and define instances of arterial pinching during leg flexion (as the difference in lumen diameters between straight and flexed leg positions).
The geometries of the arterial lumens will be combined with their corresponding 3D arterial centerlines to generate patient-specific arterial models. Along with patient-specific boundary conditions obtained from DU measurements, these models will be transferred to a commercial software, to perform Computational Fluid Dynamics analyses. The changes in these parameters due to leg flexion, as well as due to different stent designs, will be quantified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interwoven stent | Active comparator | Device: Interwoven stentUse of an interwoven nitinol stent to treat patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery. |
| Laser-cut stent | Active comparator | Device: Laser-cut stentUse 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interwoven stentInterwoven nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery. | Device | Interwoven stent |
| Laser-cut stentLaser-cut nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery. | Device | Laser-cut stent |
Primary outcome
Primary patency
Time frame: 1 year post index procedure
Primary patency of the target lesion measured by duplex ultrasound
1 secondary outcome
Changes in arterial flow within the target lesion
Time frame: 6 weeks, 6 months, and 1 year post index procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aljoscha Rastan principal investigator
Kantonsspital Aarau
Questions about this trial
What is this clinical trial studying?
A study testing Interwoven stent and Laser-cut stent in people with Peripheral Arterial Disease and Popliteal Artery Stenosis, run by Kantonsspital Aarau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 1 year post index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.