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

Peripheral Arterial Disease Clinical Trial

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02580955
• Other study ID #: FMRP-150527
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: January 2019

Study information

• Verified date: August 2018
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• LEGFLOW DCB

Locations

Country	Name	City	State
Belgium	OLV Hospital	Aalst
Belgium	Imelda Hospital Bonheiden	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	Heilig Hart Hospital	Tienen

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

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