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

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ClinicalTrials.gov Identifier: NCT02962232
Recruitment Status : Recruiting
First Posted : November 11, 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 to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.

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

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

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 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 Name: 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 Name: AMPHIRION DEEP




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. change of the Rutherford score [ Time Frame: in day 0-30, 6th month, 12th month post operation ]
  5. change of the life equality by EQ5D [ Time Frame: in day 0-30, 6th month, 12th month post operation compares to baseline ]
  6. 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;

  7. target lesion revascularization rate [ Time Frame: in day 0-30, 6th month, 12th month post operation ]
  8. target limb upper amputation and lower amputation rate [ Time Frame: in day 0-30, 6th month, 12th month post operation ]
  9. 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 ]


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:

  • 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;

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): NCT02962232


Contacts
Contact: Chen zhong, professor chenzhong8658@vip.sina.com

Locations
China, Fujian
The First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China
Contact: Guo pingfan, professor       13960721962@163.com   
Principal Investigator: Guo pingfan, professor         
China, Hainan
Hainan General Hospital Recruiting
Haikou, Hainan, China
Contact: Xiao Zhanxiang, professor         
Contact       xiaozhanxianghn@sina.com   
Principal Investigator: Xiao Zhanxiang, professor         
China, Hebei
Hebei General Hospital Recruiting
Shijiazhuang, Hebei, China
Contact: Shi xiaoming, a. professor       shixiaoming1999@126.com   
Principal Investigator: Shi xiaoming, a.professor         
The First Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China
Contact: Zhang Lei, professor       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       huangjianhua@medmail.com.cn   
Principal Investigator: Huang jianhua, professor         
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Zhang Xiwei, professor       xiwei1092@163.com   
Principal Investigator: Zhang Xiwei, professor         
China, Jiangxi
The Second Affiliated Hospital of Nanchang University Not yet recruiting
Nanchang, Jiangxi, China
Contact: Zhou weimin, professor       drzwm@sina.com   
Principal Investigator: Zhou weimin, professor         
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China
Contact: Tian Hongyan, professor       tianhhyyxg@163.com   
Principal Investigator: Tian Hongyan, professor         
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Zhao       xgwkzjc@163.com   
Contact: Jichun         
Principal Investigator: Zhao Jichun, professor         
China
Beijing Anzhen Hospital Capital Medical University Recruiting
Beijing, China
Contact: zhong Chen       chenzhong8658@vip.sina.com   
Beijing Chao-Yang Hospital Recruiting
Beijing, China
Contact: Zhang wangde, professor       drwangde@vip.sina.com   
Principal Investigator: Zhang wangde, professor         
Beijing Frendship Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Chen xueming, professor       chenxueming04@sohu.com   
Principal Investigator: Chen xueming, 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: Luo Xiaoyun, A. professor       paperWord@vip.163.com   
Principal Investigator: Luo Xiaoyun, A. professor         
Chinese PLA General Hospital Recruiting
Beijing, China
Contact: Guo wei, professor       pla301dml@vip.sina.com   
Principal Investigator: Guo wei, professor         
Fuwai Hospital, Chinese Accadamy of Medical Sciences Recruiting
Beijing, China
Contact: Shu Chang, professor       changshu@yahoo.com   
Principal Investigator: Shu Chang, professor         
Renji Hospital Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, China
Contact: Zhang Lan, professor       lucky200207@aliyun.com   
Principal Investigator: Zhang Lan, professor         
Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Contact: Jiang mi'er, professor       jiangme2013@163.com   
Principal Investigator: Jiang mi'er, professor         
Tianjing Medical University General Hospital Recruiting
Tianjin, China
Contact: Dai xiangchen, professor       13302165917@163.com   
Principal Investigator: Dai xiangchen, professor         
Sponsors and Collaborators
ZhuHai Cardionovum Medical Device Co., Ltd.
Investigators
Principal Investigator: Chen zhong, professor Beijing Anzhen Hospital

Responsible Party: ZhuHai Cardionovum Medical Device Co., Ltd.
ClinicalTrials.gov Identifier: NCT02962232     History of Changes
Other Study ID Numbers: LEGFLOW-2015-02
First Posted: November 11, 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
arterial vasculature below the knee

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