A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW

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

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

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee 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 to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion inbelow the knee artery.

This is a prospective, multi-center, randomized, control, opening, superiority designed clinical study. Plan to enroll 172 eligible subjects in 15 centers in China, all these subjects will be randomized 1:1 to the study group (LEGFLOW OTW group, n=86) and control group (AMPHIRION DEEP group, n=86), and accept the treatment of LEGFLOW OTW and AMPHIRION DEEP respectively.

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
        • Chinese PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Guo wei, professor
      • Beijing, China
      • Beijing, China
      • Beijing, China
        • Recruiting
        • Beijing Frendship Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Chen xueming, professor
      • Beijing, China
        • Recruiting
        • Beijing Shijitan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Luo Xiaoyun, A. 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
        • Not yet recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Zhang Lan, professor
      • Tianjin, China
        • Recruiting
        • Tianjing Medical University General Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Hainan
      • Haikou, Hainan, China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei General Hospital
        • Contact:
        • Principal Investigator:
          • Shi xiaoming, a.professor
      • Shijiazhuang, Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Principal Investigator:
          • Zhang Xiwei, professor
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • Zhou weimin, professor
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:
          • Jichun
        • Principal Investigator:
          • Zhao Jichun, professor

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age from 18 to 85 years (include 18 and 85 year);
  • critical limb ischemia subjects (Rutherford classification from 3 to 6)
  • expective survival more than 1 year;
  • can understand the study objective, self willing enrolls and sign the informed consent, and accept scheduled followed up at the specific time.

Angiographic inclusive criteria:

  • reference vessel diameter 2.0-3.5mm;
  • stenosis or occlusion in arterial vasculature below the knee shall have distal outflow;
  • target lesion stenosis ≥70% or occlusion, length ≤270mm;

  • if subject has ipsilateral / contralateral iliac lesions, the iliac lesion shall meet all the following criteria:

    • iliac lesion or occlusion length ≤100mm and
    • shall be treated earlier than the target lesion and
    • shall be treated successfully. the successful treatment standard: 1) residual stenosis <30%; 2) without flow limiting dissection 3) without thrombosis, embolism or any other serious adverse events

Exclusion Criteria:

  • subjects currently participate in other drugs or medical devices clinical study and have not reach the primary endpoint;
  • childbearing aged women whose pregnancy test before intervention operation is not negative, and lactating mothers;
  • subjects with renal function insufficiency (serum creatinine> 2.5mg / dL or in renal dialysis);
  • subjects have known be allergy or contraindication to the contrast agent, paclitaxel, heparin, antiplatelet, anticoagulant or thrombolytic agents;
  • subjects plan to a major amputation (over metatarsal level);
  • stroke subjects within 3 months or stroke subjects with severe hemiplegia and aphasia associated sequelaes over 3 months before the intervention operation;
  • subjects with acute myocardial infarction, thrombolytic therapy or angina within 30 days before the intervention operation;
  • subjects whose target lesion limb have gangrene (the gangrene range over the metatarsophalangeal joint);
  • target lesion is a stenosis or occlusion that have prior been treated by scaffold implantation, DEB, ordinary balloon catheter or bypass graft;
  • lesions and /or occlusion locate or extend to popliteal artery or below ankle joint;
  • subjects requiring be intervention in bilateral lower limb;
  • the stenosis lesion of ipsilateral femoral artery or ipsilateral popliteal artery have a diameter stenosis ≥50% untreated before the intervention operation;
  • ipsilateral femoral artery or ipsilateral popliteal artery has single or adjacent lesion length ≥15cm, or ipsilateral femoral artery or ipsilateral popliteal artery has multiple lesion and one of these multiple lesion length ≥10cm or occlusion;
  • - adjacent lesion: 1) interval no more than 30 mm, 2) can be treated as a single lesion;
  • - multiple lesion: 1) interval no more than 30 mm, 2) need to be treated as multiple lesion;
  • the residual stenosis still ≥30%, even when the length <15cm and stenosis ≥50% single or adjacent lesion in ipsilateral femoral artery or ipsilateral popliteal artery has been treated, or when each lesion length <10cm and stenosis ≥50% multiple lesion in ipsilateral femoral artery or ipsilateral popliteal artery has been treated;
  • DES and /or DEB has been used in the inflow vessel of lesions treatment;
  • subject has no patency vessel below the ankle artery before the intervention operation;
  • target vessel aneurysm;
  • acute or subacute thrombosis in target vessel;
  • angiography shows severe calcification in the target lesion (before contrast injection or digital subtraction angiography, intensive annular calcifications that make target lesion not expansion and / or a calcification within the target lesion and locate on either sides of the vessel wall whose continuous length over than 5cm);
  • lesions that the guild wire cannot pass through;
  • subjects need be treated by thrombus endarterectomy, percutaneous transluminal plaque circumcision or laser treatment device indicate by intraoperative angiography;

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LEGFLOW OTW group
in the LEGFLOW OTW group the subject will be treated by the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW)
Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
treatment group
Other Names:
  • LEGFLOW OTW
Active Comparator: AMPHIRION DEEP group
in the AMPHIRION DEEP group the subject will be treated by PTA catheter (AMPHIRION DEEP)
Device: PTA catheter
control group
Other Names:
  • AMPHIRION DEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion restenosis determined by CTA
Time Frame: 6 month post procedure

Restenosis defined as within the ± 5mm range beyond proximal and / or distal of target lesion, the lumen loss is greater than 50% of the reference vessel lumen diameter (RVD) follow-up by CTA.

Target lesion revascularization (TLR): clinical symptoms of peripheral arterial disease recurrence or worsening, and any target lesion re-intervention caused by diameter stenosis ≥50% (confirmed by Doppler ultrasound, DSA or CT angiography).
6 month post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
device success rate
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
operation success rate
Time Frame: at 0-30 days
operation 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
clinical success rate
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 of the Rutherford score
Time Frame: in day 0-30, 6th month, 12th month post operation
in day 0-30, 6th month, 12th month post operation
change of the life equality by EQ5D
Time Frame: in day 0-30, 6th month, 12th month post operation compares to baseline
in day 0-30, 6th month, 12th month post operation compares to baseline
target limb ulcer healing rate
Time Frame: in day 0-30, 6th month, 12th month post operation
healing or not, if not: improve, no change, or progression;
in day 0-30, 6th month, 12th month post operation
target lesion revascularization rate
Time Frame: in day 0-30, 6th month, 12th month post operation
in day 0-30, 6th month, 12th month post operation
target limb upper amputation and lower amputation rate
Time Frame: in day 0-30, 6th month, 12th month post operation
in day 0-30, 6th month, 12th month post operation
major adverse event rate including all cause death, target limb upper amputation and target lesion revascularization
Time Frame: in day 0-30, 6th month, 12th month post operation
in day 0-30, 6th month, 12th month post operation

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: Chen zhong, professor, Beijing Anzhen 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

November 1, 2016

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 11, 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-2015-02

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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