Peripheral Arterial DiseasePhase 2/3NCT02430922
a Physician-inititated Trial Investigating the iVolution Nitinol Stent
A Phase 2/3 study testing iVolution nitinol stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.
Trial summary
The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions. 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?
- iVolution nitinol stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesBelgium
- Study dates
- Apr 2015to Dec 2017
- Phase
- Phase 2/3
- 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
- De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
- Patient presenting with a score from 2 to 4 according to the Rutherford classification
- Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
- Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint
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- The target lesion has angiographic evidence of stenosis or occlusion
- Length of the target lesion is ≤ 15 cm by visual estimation
- Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
- There is angiographic evidence of at least one vessel-runoff to the foot
Who cannot join
- Presence of a stent in the target vessel that was placed during a previous procedure
- Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- Previous bypass 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
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- Patients with known hypersensitivity to nickel-titanium or other study device components
- Patients with uncorrected bleeding disorders
- Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- Life expectancy of less than 12 months
- Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
- Use of thrombectomy, atherectomy or laser devices during 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
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
OLV Aalst
Aalst, Oost-Vlaanderen, 9300
Imelda Hospital
Bonheiden, Antwerp, 2820
A.Z. Sint-Blasius
Dendermonde, East-Flanders, 9200
Heilig-Hart Ziekenhuis
Tienen, Flemish Brabant, 3300
About this study
Official title: EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions
The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.
- Conditions
- Peripheral Arterial Disease
- Being tested
- iVolution nitinol 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.
iVolution nitinol stentDevice
| Study group | Role | What they receive |
|---|---|---|
| iVolution stent | Experimental | Patient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions. Receives: Device: iVolution nitinol stent |
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 at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention
Measured: 12 months
Secondary outcomes (5)
Technical Success
Measured: Procedure
Primary Patency at 1 & 6 months
Measured: 1 & 6 months
Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months
Measured: at all follow-up visits
Clinical Success at 1, 6 and 12 months
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6- \& 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Measured: at all follow-up visits
Serious adverse events until follow-up completions
Any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: 1,6,12 months and interem visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marc Bosiers, MD, Principal investigator, Flanders Medical Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430922
- Sponsor's protocol ID
- FMRP-150106
- Status last verified
- Aug 2018
- First submitted
- 27 Apr 2015
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions
- ClinicalTrials.gov ID
- NCT02430922
- Acronym / sponsor ID
- FMRP-150106
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Apr 2015 (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 objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iVolution stent | Experimental | Device: iVolution nitinol stentPatient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
- Patient presenting with a score from 2 to 4 according to the Rutherford classification
- Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
- Patient is >18 years old
- Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
Key exclusion criteria (14 listed)
- Presence of a stent in the target vessel that was placed during a previous procedure
- Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- Previous bypass 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
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 |
|---|---|---|
| iVolution nitinol stent | Device | iVolution stent |
Primary outcome
Primary Patency at 12 months
Time frame: 12 months
freedom from >50% restenosis at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention
5 secondary outcomes
Technical Success
Time frame: Procedure
Primary Patency at 1 & 6 months
Time frame: 1 & 6 months
Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months
Time frame: at all follow-up visits
Clinical Success at 1, 6 and 12 months
Time frame: at all follow-up visits
Serious adverse events until follow-up completions
Time frame: 1,6,12 months and interem visits
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 13 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Peripheral Arterial Disease
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.
Marc Bosiers, MD principal investigator
Flanders Medical Research Program
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing iVolution nitinol stent in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.
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 10 inclusion and 14 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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). 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 13 Aug 2018.