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

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).

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: LEGFLOW DCB

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Hospital
  • Bonheiden, Belgium, 2820
    • Imelda Hospital Bonheiden
  • Dendermonde, Belgium, 9200
    • AZ Sint-Blasius
  • Tienen, Belgium, 3300
    • Heilig Hart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient presenting a score from 2 to 5 following Rutherford classification
2. Patient is willing to comply with specified follow-up evaluations at the specified times
3. Patient is >18 years old
4. Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
5. Patient has a projected life expectancy of at least 12 months
6. Prior to enrolment, the guidewire has crossed target lesion
7. Patient is eligible for treatment with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
8. 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
9. De novo lesion located in the femoropopliteal arteries suitable for endovascular therapy
10. The target lesion is located within the native femoropopliteal artery
11. The length of the target lesion is > 150mm and considered as TASC C or D lesion according to the TASC II classification.
12. The target lesion has angiographic evidence of stenosis > 50% or occlusion which can be passed with standard guidewire manipulation
13. Target vessel diameter visually estimated is >4mm and <6.5 mm
14. 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:

1. Patient refusing treatment
2. Presence of a stent in the target lesion that was placed during a previous procedure
3. Untreated flow-limiting inflow lesions
4. Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
5. Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
6. Previous bypass surgery in the same limb
7. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
8. Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
9. Perforation at the angioplasty site evidenced by extravasation of contrast medium
10. Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
11. Patients with uncorrected bleeding disorders
12. Aneurysm located at the level of the SFA
13. Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
14. 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
15. Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
16. Septicemia or bacteremia
17. Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis >30% or ipsilateral iliac treatment conducted after the target lesion procedure
18. Use of thrombectomy, atherectomy or laser devices during procedure
19. Any patient considered to be hemodynamically unstable at onset of procedure
20. Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
21. Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEGFLOW DCB; patients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter	Device: LEGFLOW DCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary Patency rate at 1 & 6 month follow-up	1 month, 6 months
Technical success	during procedure, at baseline
Freedom from TLR at 1,6 and 12-month follow-up	1 month, 6 months, 12 months
Clinical success at follow-up, defined as an improvement of Rutherford classification at all follow-up time points	12 months
Serious adverse events	12 months

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FMRP-150527