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

NCT02580955 | Unknown Phase 3

• 1 other identifier: FMRP-150527
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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 treatment of long femoropopliteal lesions (TASC C\&D).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (5)

• 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

Study Arms (1)

LEGFLOW DCB

EXPERIMENTAL

patients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter

Device: LEGFLOW DCB

Interventions

LEGFLOW DCB DEVICE

LEGFLOW DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

OLV Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital Bonheiden

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

Heilig Hart Hospital

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

BE (4)