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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
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program

Tracking Information
First Submitted Date  ICMJE October 19, 2015
First Posted Date  ICMJE October 20, 2015
Last Update Posted Date August 13, 2018
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • Primary Patency rate at 1 & 6 month follow-up [ Time Frame: 6 months ]
  • Technical success [ Time Frame: during procedure, at baseline ]
  • Freedom from TLR at 1,6 and 12-month follow-up [ Time Frame: 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REFLOW Study, Investigating the Efficacy of the LEGFLOW DCB in TASC C&D Fempop Lesions
Official Title  ICMJE 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).
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE Device: LEGFLOW DCB
Study Arms  ICMJE Experimental: LEGFLOW DCB
patients treated with the LEGFLOW Paclitaxel-Eluting Peripheral Balloon Dilatation Catheter
Intervention: Device: LEGFLOW DCB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 19, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02580955
Other Study ID Numbers  ICMJE FMRP-150527
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Flanders Medical Research Program
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Flanders Medical Research Program
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Flanders Medical Research Program
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP