A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW

November 27, 2018 updated by: ZhuHai Cardionovum Medical Device Co., Ltd.

Evaluation of the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Femoral-popliteal Arteries：A Prospective, Multicenter, Randomized, Controlled Clinical Study

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

This is a prospective, multicenter, prior desiged, randomize and controlled study, planned to enrol 172 subjects. all these subjects will be allocated 1:1 to the LEGFLOW OTW group n=86 and Admiral Xtreme group n=86. and accept the treatment of LEGFLOW and Admiral Xtreme balloon. and followed up at day 0-30, month 6, 12 by DUS and clinical examination. all the endpoint data will be assessed by DUS core-lab, CEC, then be statisticed.

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Hospital
      • Beijing, China
        • Recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contact:
      • Beijing, China
        • Not yet recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Chen Zhong, professor
      • Beijing, China
        • Recruiting
        • Beijing Shijitan Hospital, Capital Medical University
        • Contact:
          • Zhang Fuxian, professor
          • Phone Number: 010-63926252
          • Email: fuxian@263.net
        • Principal Investigator:
          • Zhang Fuxian, professor
      • Beijing, China
        • Recruiting
        • Fuwai Hospital, Chinese Accadamy of Medical Sciences
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
        • Contact:
      • Shanghai, China
        • Enrolling by invitation
        • Longhua Hospital Shanghai University of Tranditional Chinese Medicine
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
          • Guo Pingfan, professor
          • Phone Number: 0591-87982072
        • Contact:
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • Hainan General Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 85 years.
  2. De novo or restenotic lesions in the femoral popliteal artery due to atherosclerosis, which located in the superficial femoral artery and/or proximal popliteal artery (arterial segment starting at least 1cm beyond the common femoral artery bifurcation to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella). And the patients are suitable for endovascular therapy with LEGFLOW OTW or Admiral Xtreme.
  3. Rutherford class 2 to 5.
  4. Target lesion length ≤ 200mm.
  5. Target lesion stenosis ≥ 70% or total occlusion, and it can be passed with common manipulation.
  6. Reference vessel diameter ≥ 4mm and ≤ 8mm by visual estimate.

  7. Target lesion consists of a single of de novo or restenotic lesion, or a adjacent lesion or a combination lesion or multiple lesion which meets the following criteria:

    • adjacent lesion: (1) lesion space ≤ 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as a single lesion.
    • Combination lesion: combination lesion is defined as not a chronic total occlusion (CTO), but may include a part of total occlusion (100% stenosis). The total lesion length ≤ 200mm.
    • Multiple lesion: (1) lesion space > 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as multiple lesions.
  8. Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel is patent, defined as < 50% diameter stenosis), whether or not this outfolw was re-established by previous intervention.

  9. If subject has ipsilateral/contralateral iliac disease that requires treatment during the procedure, the iliac lesions must meet all the following criteria:

    • Iliac lesion or occlusion is ≤ 100mm in length;
    • must be treated before the target lesion (superficial femoral artery/proximal popliteal artery).
    • must be successfully treated before target lesion treatment; success is defined as: (1) residual stenosis < 30%; (2) free of dissection which can limit blood flow; (3) no occurrence of thrombus, embolization, or other SAE.
  10. Life expectancy more than one year.
  11. Understands the study objective and is willing to participate and provide the informed consent form, and is willing to comply with specified follow-up evaluations at the specified time points.

Exclusion Criteria:

  1. Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
  2. Stroke or STEMI within 30 days prior to the procedure.
  3. Either local or systemic thrombolytic therapy within 6 weeks prior to the procedure.
  4. Any major surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
  5. Any major selective surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
  6. Restenotic lesions after DCB or bypass surgery.
  7. Target limb has been previously treated with bypass surgery.
  8. Guidewire must be passed through from the distal part of limb.
  9. Known allergies or sensitivities to contrast agent, paclitaxel, anti-platelet, anticoagulants or thrombolytic drugs.
  10. Known allergies or sensitivities to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II.
  11. Aneurysm located at the target vessel.
  12. Acute or sub-acute thrombosis in the target vessel.
  13. Angiographic evidence of severe calcification (defined as dense circumferential calcification that makes the target lesion non-dilatable and/or calcificatin that is present on both sides of the vessel wall and that extends more than 5 cntinuous centimeters in length within the target lesion prior to contrast injection or digital subtraction angiography).
  14. The bilateral lower limb must be treated in one procedure.
  15. Uncorrected bleeding disorder.
  16. Renal insufficiency (serum creatinine >2.5mg/dL or renal dialysis).
  17. Stenosis or occlusions due to non-atherosclerosis, such as thrombotic occlusive vasculitis or vasculitis.
  18. Septicemia or bacteremia.
  19. Patients with severe disease (such as severe chronic obstructive pulmonary disease, malignant tumor, dementia, etc.) or patient's physical condition may affect the compliance with this study.
  20. Pre-dilation resulted in a major (≥ Grade D) flow-limiting dissection or residual stenosis > 70%.
  21. Major distal amputation (above the transmetatarsal) in the study limb or non-study limb.
  22. Patients who have participated in another investigational drug or device trial that has not completed the primary endpoint.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LEGFLOW OTW group
in this group subject will be treated by Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) and followed up
Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter
Other Names:
  • LEGFLOW OTW
ACTIVE_COMPARATOR: Admiral Xtreme
in this group subject will be treated by Peripheral Balloon Dilatation Catheter (Admiral Xtreme) and followed up
Device: Peripheral Balloon Dilatation Catheter
in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter
Other Names:
  • Admiral Xtreme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinically driven target lesion revascularization (CD-TLR)
Time Frame: 12 month post procedure
12 month post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: at 0-30 days
Procedural Success defines as the blood supply of the target lesion regained after treatment, residual stenosis less than 50% and without flow-limiting dissection (≥type D) occurred.
at 0-30 days
Device Success
Time Frame: at 0-30 days
Device Success defines as the device successfully delivered to the target location, inflated, deflated and withdrawn from the treated balloon inflation tube.
at 0-30 days
Clinical Success
Time Frame: at 0-30 days
Clinical Success defines as operation success, and without any postoperative complication before discharge (death, lesions limb amputation, target lesion thrombosis or TVR)
at 0-30 days
Change in Rutherford classification measured
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Change in ABI measure
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Walking capacity assessment by Walking Impairment Questionnaire (WIQ)
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Walking distance assessment by Six Minute Walk Test (6MWT)
Time Frame: 0-30 days, 6 months and 12 months post procedure compared with baseline
0-30 days, 6 months and 12 months post procedure compared with baseline
Quality of life assessment by EQ5D
Time Frame: at 0-30 days, 6 months and 12 months post procedure compared with baseline
at 0-30 days, 6 months and 12 months post procedure compared with baseline
Target lesion revascularization (TLR)
Time Frame: 0-30 days, 6 months and 12 months post procedure
0-30 days, 6 months and 12 months post procedure
Target vessel revascularization (TVR)
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Thrombus at the target lesion site
Time Frame: 0-30 days, 6 months and 12 months post procedure
0-30 days, 6 months and 12 months post procedure
Target limb amputation rates
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Major Adverse Event (MAE) rate which including all cause death, CD-TLR and major target limb amputation.
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Clinical-driven target vessel revascularization (CD-TVR) rates
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure
Clinical-driven target lesion revascularization (CD-TLR) rates
Time Frame: at 0-30 days, 6 months and 12 months post procedure
at 0-30 days, 6 months and 12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZhuHai Cardionovum Medical Device Co., Ltd.

Investigators

  • Principal Investigator: Guo Wei, professor, Chinese PLA Genral Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (ESTIMATE)

November 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEGFLOW-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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