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A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW

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ClinicalTrials.gov Identifier: NCT02965677
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
ZhuHai Cardionovum Medical Device Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter Device: Peripheral Balloon Dilatation Catheter Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
Drug Information available for: Paclitaxel

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 Name: 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 Name: Admiral Xtreme




Primary Outcome Measures :
  1. clinically driven target lesion revascularization (CD-TLR) [ Time Frame: 12 month post procedure ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. Change in Rutherford classification measured [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]
  5. Change in ABI measure [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]
  6. Walking capacity assessment by Walking Impairment Questionnaire (WIQ) [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]
  7. Walking distance assessment by Six Minute Walk Test (6MWT) [ Time Frame: 0-30 days, 6 months and 12 months post procedure compared with baseline ]
  8. Quality of life assessment by EQ5D [ Time Frame: at 0-30 days, 6 months and 12 months post procedure compared with baseline ]
  9. Target lesion revascularization (TLR) [ Time Frame: 0-30 days, 6 months and 12 months post procedure ]
  10. Target vessel revascularization (TVR) [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]
  11. Thrombus at the target lesion site [ Time Frame: 0-30 days, 6 months and 12 months post procedure ]
  12. Target limb amputation rates [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]
  13. 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 ]
  14. Clinical-driven target vessel revascularization (CD-TVR) rates [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]
  15. Clinical-driven target lesion revascularization (CD-TLR) rates [ Time Frame: at 0-30 days, 6 months and 12 months post procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965677


Contacts
Contact: Guo Wei, professor 010-66938349 pla301dml@vip.sina.com

Locations
China, Fujian
The First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China
Contact: Guo Pingfan, professor    0591-87982072      
Contact: Wu Jie, doctor    13960721962    13960721962@163.com   
Principal Investigator: Guo Pingfan, professor         
China, Hainan
Hainan General Hospital Recruiting
Haikou, Hainan, China
Contact: Xiao Zhanxiang, professor    0898-68622045    xiaozhanxianghn@sina.com   
Principal Investigator: Xiao Zhanxiang, professor         
China, Hebei
The First hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China
Contact: Zhang Lei, professor    0311-85917096    drleizhang@163.com   
Principal Investigator: Zhang Lei, professor         
China, Hunan
Xiangya Hospital Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Huang Jianhua, professor    0731-84327196    huangjianhua@medmail.com.cn   
Principal Investigator: Huang Jianhua, professor         
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China
Contact: Tian Hongyan, professor    029-85324128/029-85    tianhhyyxg@163.com   
Principal Investigator: Tian Hongyan, professor         
China
Beijing Anzhen Hospital, Capital Medical University Not yet recruiting
Beijing, China
Contact: Chen Zhong, professor    010-84005219    chenzhong8658@vip.sina.com   
Principal Investigator: Chen Zhong, professor         
Beijing Chao-yang Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Zhang Wangde, professor    010-85231886    drwangde@vip.sina.com   
Principal Investigator: Zhang Wangde, professor         
Beijing Hospital Recruiting
Beijing, China
Contact: Li Yongjun, professor       yongjun.li@foxmail.com   
Principal Investigator: Li Yongjun, professor         
Beijing Shijitan Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Zhang Fuxian, professor    010-63926252    fuxian@263.net   
Principal Investigator: Zhang Fuxian, professor         
Fuwai Hospital, Chinese Accadamy of Medical Sciences Recruiting
Beijing, China
Contact: Shu Chang    010-88322377    changshu01@yahoo.com   
Principal Investigator: Shu Chang, professor         
Longhua Hospital Shanghai University of Tranditional Chinese Medicine Enrolling by invitation
Shanghai, China
Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Contact: Jiang Mi'er, professor    021-23271699-5199    jiangme2013@163.com   
Principal Investigator: Jiang Mi'er, professor         
Tianjin Medical University General Hospital Recruiting
Tianjin, China
Contact: Dai Xiangchen, professor    022-60362209    13302165917@163.com   
Principal Investigator: Dai Xiangchen, professor         
Sponsors and Collaborators
ZhuHai Cardionovum Medical Device Co., Ltd.
Investigators
Principal Investigator: Guo Wei, professor Chinese PLA Genral Hospital

Responsible Party: ZhuHai Cardionovum Medical Device Co., Ltd.
ClinicalTrials.gov Identifier: NCT02965677     History of Changes
Other Study ID Numbers: LEGFLOW-2015-01
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by ZhuHai Cardionovum Medical Device Co., Ltd.:
drug eluting balloon
Femoral Popliteal Artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action