Peripheral Arterial DiseaseVMI-CFANCT02804113
Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
A study testing Supera Peripheral Stent System in people with Peripheral Arterial Disease, run by ID3 Medical at 7 sites in 2 countries.
Trial summary
The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Supera Peripheral Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Apr 2016to 30 Oct 2019
- 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
- Patient presenting a score from 2 to 4 following Rutherford classification
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life expectancy of at least 12 months
- Prior to enrolment, the guidewire has crossed target lesion
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- De novo lesions located in the common femoral artery, suitable for endovascular therapy
- The target lesions are located within the native CFA: localized between the origin of the circumflex iliac artery and the proximal (1cm) superficial femoral artery.
- There is angiographic evidence of a patent deep femoral artery
- The target lesion has angiographic evidence of stenosis > 50% or occlusion
- There is angiographic evidence of at least one-vessel-runoff to the foot, irrespective of whether or not outflow was re-established by means of previous endovascular intervention
Who cannot join
- Presence of another stent in the target vessel that was placed during a previous procedure
- Previous open surgery in the same limb
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site.
- Perforation at the angioplasty site evidenced by extravasation of contrast medium
- Patients with known hypersensitivity to nickel-titanium and heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
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- Patients with uncorrected bleeding disorders
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatment with a residual stenosis>30%
- Use of thrombectomy, atherectomy or laser devices during procedure
- Any planned surgical intervention/procedure 30 days after the study procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
- Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
- Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
- Septicemia or bacteremia
- Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Belgium4 sites
OLV Ziekenhuis Aalst
Aalst, Oost-Vlaanderen, 9300
ZNA Stuivenberg
Antwerp, Antwerp, 2060
Imelda Hospital
Bonheiden, 2820
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, 9200
France3 sites
Clinique Rhone Durance
Avignon, 84000
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
CHU de Nantes
Nantes, 44093
About this study
Official title: VMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Supera Peripheral Stent System
- 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.
Supera Peripheral Stent SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Supera Peripheral Stent System | Experimental | Not described Receives: Device: Supera Peripheral Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency at 12 months
freedom from > 50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention (TLR) within 12 months.
Measured: 12 months
Periprocedural adverse events
periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011
Measured: 30 days post procedure
Secondary outcomes (4)
Technical success
ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.
Measured: during indexprocedure
Primary patency rate at 1, 6 and 24 month
freedom from >50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no intervention within 1 and 6 months.
Measured: 1, 6 and 24 month post procedure
Freedom from TLR until 24 month post procedure
freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Measured: until 24 month post procedure
Clinical success
an improvement of Rutherford classification at 1-, 6-, 12- and 24-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 1, 6, 12 and 24 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start25 Apr 2016
- Primary completion30 Jun 2018
- Study completion30 Oct 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ID3 Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Study director, ID3 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804113
- Sponsor's protocol ID
- iD3 Medical - 160226
- Acronym
- VMI-CFA
- Status last verified
- Jan 2021
- First submitted
- 14 Jun 2016
- Last updated
- 6 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery
- ClinicalTrials.gov ID
- NCT02804113
- Acronym / sponsor ID
- VMI-CFA / iD3 Medical - 160226
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ID3 MedicalUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 17 Jun 2016 (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 VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supera Peripheral Stent System | Experimental | Device: Supera Peripheral Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient presenting a score from 2 to 4 following Rutherford classification
- Patient is willing to comply with specified follow-up evaluations at the specified times
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient has a projected life expectancy of at least 12 months
Key exclusion criteria (17 listed)
- Presence of another stent in the target vessel that was placed during a previous procedure
- Previous open surgery in the same limb
- Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
- Patients who exhibit persistent acute intraluminal thrombus at the target lesion site.
- Perforation at the angioplasty site evidenced by extravasation of contrast medium
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 Peripheral Stent System | Device | Supera Peripheral Stent System |
Primary outcome
Primary patency at 12 months
Time frame: 12 months
freedom from > 50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention (TLR) within 12 months.
Periprocedural adverse events
Time frame: 30 days post procedure
periprocedural adverse events up to 30 days post procedure, as defined per ISO 14155:2011
4 secondary outcomes
Technical success
Time frame: during indexprocedure
Primary patency rate at 1, 6 and 24 month
Time frame: 1, 6 and 24 month post procedure
Freedom from TLR until 24 month post procedure
Time frame: until 24 month post procedure
Clinical success
Time frame: 1, 6, 12 and 24 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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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.
Koen Deloose, MD study director
ID3 Medical
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supera Peripheral Stent System in people with Peripheral Arterial Disease, run by ID3 Medical at 7 sites in 2 countries.
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 11 inclusion and 17 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: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 6 Jan 2021.