REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions
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ClinicalTrials.gov Identifier: NCT02580955 |
Recruitment Status : Unknown
Verified August 2018 by Flanders Medical Research Program.
Recruitment status was: Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : August 13, 2018
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease | Device: LEGFLOW DCB | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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). |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: LEGFLOW DCB
patients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
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Device: LEGFLOW DCB |
- 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 ]
- Primary Patency rate at 1 & 6 month follow-up [ Time Frame: 1 month, 6 months ]
- Technical success [ Time Frame: during procedure, at baseline ]
- Freedom from TLR at 1,6 and 12-month follow-up [ Time Frame: 1 month, 6 months, 12 months ]
- Clinical success at follow-up, defined as an improvement of Rutherford classification at all follow-up time points [ Time Frame: 12 months ]
- Serious adverse events [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580955
Belgium | |
OLV Hospital | |
Aalst, Belgium, 9300 | |
Imelda Hospital Bonheiden | |
Bonheiden, Belgium, 2820 | |
AZ Sint-Blasius | |
Dendermonde, Belgium, 9200 | |
Heilig Hart Hospital | |
Tienen, Belgium, 3300 |
Responsible Party: | Flanders Medical Research Program |
ClinicalTrials.gov Identifier: | NCT02580955 |
Other Study ID Numbers: |
FMRP-150527 |
First Posted: | October 20, 2015 Key Record Dates |
Last Update Posted: | August 13, 2018 |
Last Verified: | August 2018 |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |