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Peripheral Arterial DiseasePhase 3NCT02580955

REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions

A Phase 3 study testing LEGFLOW DCB in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm. Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the… 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?
LEGFLOW DCB
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
Oct 2015to Jan 2019
Phase
Phase 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

  • Patient presenting a score from 2 to 5 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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  • Patient is eligible for treatment with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
  • Male, infertile female or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
  • De novo lesion located in the femoropopliteal arteries suitable for endovascular therapy
  • The target lesion is located within the native femoropopliteal artery
  • The length of the target lesion is > 150mm and considered as TASC C or D lesion according to the TASC II classification.
  • The target lesion has angiographic evidence of stenosis > 50% or occlusion which can be passed with standard guidewire manipulation
  • Target vessel diameter visually estimated is >4mm and <6.5 mm
  • 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

  • Patient refusing treatment
  • Presence of a stent in the target lesion that was placed during a previous procedure
  • Untreated flow-limiting inflow lesions
  • Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
  • Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
  • Previous bypass surgery in the same limb
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  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
  • Perforation at the angioplasty site evidenced by extravasation of contrast medium
  • Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
  • Patients with uncorrected bleeding disorders
  • Aneurysm located at the level of the SFA
  • Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
  • Severe medical comorbidities (untreated CAD/CHF, sever 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
  • Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis >30% or ipsilateral iliac treatment conducted after the target lesion procedure
  • Use of thrombectomy, atherectomy or laser devices during procedure
  • Any patient considered to be hemodynamically unstable at onset of procedure
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
  • Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • OLV Hospital

    Aalst, 9300

  • Imelda Hospital Bonheiden

    Bonheiden, 2820

  • AZ Sint-Blasius

    Dendermonde, 9200

  • Heilig Hart Hospital

    Tienen, 3300

Other trials in Belgium

About this study

Official title: ReFlow Study, a Physician-initiated Trial Investigating the Efficacy of the LegFlow Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter for the Treatment of Femoropopliteal Lesions Longer Than 15cm (TASC C&D Lesions).

A physician initiated trial investigating the LEGFLOW Paclitaxel-Eluting Peripheral Balloon dilatation catheter for the treatment of femoropopliteal lesions longer than 15cm.

Objective: to evaluate the short-term outcome of the treatment by means of the LEGFLOW Paclitaxel-Eluting Peripheral BAlloon Dilattaion for the treatment of long femoropopliteal lesions (TASC C\&D).

Being tested
LEGFLOW DCB
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.

  • LEGFLOW DCBDevice

Study groups in NCT02580955
Study groupRoleWhat they receive
LEGFLOW DCBExperimentalpatients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
Receives: Device: LEGFLOW DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.

    Measured: 12 months

Secondary outcomes (5)

  1. Primary Patency rate at 1 & 6 month follow-up

    Measured: 1 month, 6 months

  2. Technical success

    Measured: during procedure, at baseline

  3. Freedom from TLR at 1,6 and 12-month follow-up

    Measured: 1 month, 6 months, 12 months

  4. Clinical success at follow-up, defined as an improvement of Rutherford classification at all follow-up time points

    Measured: 12 months

  5. Serious adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02580955
Sponsor's protocol ID
FMRP-150527
Status last verified
Aug 2018
First submitted
19 Oct 2015
Last updated
13 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LEGFLOW DCB 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 14 inclusion and 21 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: status not confirmed, 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 phase mean?

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?

Results are not available in the source record.

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, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 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?

On the ClinicalTrials.gov record for NCT02580955.

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.

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