Femoropopliteal StenosisNCT01643746
Evaluation of Luminal Expansion Following Stenting of Femoro-popliteal Occlusive Disease
A study testing Supera Stent and Life Stent in people with Femoropopliteal Stenosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Stenosis
- What is being tested?
- Supera Stent and Life Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Dec 2017to 1 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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%
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Centre hospitalier de l'université de Montréal
Montreal, Quebec, H2L 4M1
About this study
Official title: C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent
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.
- Conditions
- Femoropopliteal Stenosis
- Being tested
- Supera Stent, Life Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supera StentDevice
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).
Life StentDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Supera stent | Active comparator | 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. Receives: Device: Supera Stent |
| LifeStent | Active comparator | 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. Receives: Device: Life Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent expansion
Difference in minimal lumen diameter (MLD), minimal lumen area (MLA) and incomplete stent expansion as defined by C-arm CT between both groups
Measured: At the completion of the intervention
Secondary outcomes (1)
Stent patency
Correlate stent opening with stent patency as documented by Doppler ultrasound at one year post implantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study start1 Dec 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Why it stopped: the study has never started. The sponsor has decided to not move forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal StenosisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Gilles Soulez, MD, MSc, Study director, Centre hospitalier de l'université de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643746
- Sponsor's protocol ID
- CE 12.048
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2012
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-arm CT Evaluation of Luminal Expansion in Stenting Severe Femoro-popliteal Atherosclerotic Disease: Supera Versus LifeStent
- ClinicalTrials.gov ID
- NCT01643746
- Acronym / sponsor ID
- CE 12.048
- Conditions
- Femoropopliteal Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study has never started. The sponsor has decided to not move forward
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Abbott Medical Devices, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Queen Elizabeth II Health Sciences Centre
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 18 Jul 2012 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supera stent | Active comparator | Device: Supera StentThe 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. |
| LifeStent | Active comparator | Device: Life StentLifeStent is likely the best reference nitinol stent for comparison because a low restenosis rate has been reported at 1 year with low target revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Supera StentAngioplasty 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). | Device | Supera stent |
| Life StentAngioplasty 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). | Device | LifeStent |
Primary outcome
Stent expansion
Time frame: At the completion of the intervention
Difference in minimal lumen diameter (MLD), minimal lumen area (MLA) and incomplete stent expansion as defined by C-arm CT between both groups
1 secondary outcome
Stent patency
Time frame: 1 year
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 20 Jul 2018.
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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.
Gilles Soulez, MD, MSc study director
Centre hospitalier de l'université de Montreal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supera Stent and Life Stent in people with Femoropopliteal Stenosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
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 5 inclusion and 7 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Stent expansion (time frame: At the completion of the intervention). 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 20 Jul 2018.