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Peripheral Arterial DiseaseNCT02965677

A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW

A study testing Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter in people with Peripheral Arterial Disease, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
13 sitesChina
Study dates
Dec 2016to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and ≤ 85 years.
  • 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.
  • Rutherford class 2 to 5.
  • Target lesion length ≤ 200mm.
  • Target lesion stenosis ≥ 70% or total occlusion, and it can be passed with common manipulation.
  • Reference vessel diameter ≥ 4mm and ≤ 8mm by visual estimate.
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  • 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.
  • 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.
  • 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.
  • Life expectancy more than one year.
  • 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.

Who cannot join

  • Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
  • Stroke or STEMI within 30 days prior to the procedure.
  • Either local or systemic thrombolytic therapy within 6 weeks prior to the procedure.
  • Any major surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
  • Any major selective surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
  • Restenotic lesions after DCB or bypass surgery.
Show all 22Show fewer
  • Target limb has been previously treated with bypass surgery.
  • Guidewire must be passed through from the distal part of limb.
  • Known allergies or sensitivities to contrast agent, paclitaxel, anti-platelet, anticoagulants or thrombolytic drugs.
  • Known allergies or sensitivities to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II.
  • Aneurysm located at the target vessel.
  • Acute or sub-acute thrombosis in the target vessel.
  • 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).
  • The bilateral lower limb must be treated in one procedure.
  • Uncorrected bleeding disorder.
  • Renal insufficiency (serum creatinine >2.5mg/dL or renal dialysis).
  • Stenosis or occlusions due to non-atherosclerosis, such as thrombotic occlusive vasculitis or vasculitis.
  • Septicemia or bacteremia.
  • 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.
  • Pre-dilation resulted in a major (≥ Grade D) flow-limiting dissection or residual stenosis > 70%.
  • Major distal amputation (above the transmetatarsal) in the study limb or non-study limb.
  • Patients who have participated in another investigational drug or device trial that has not completed the primary endpoint.

Trial locations and contacts

13 sites in 1 country.

Guo Wei, professor contact

010-66938349

pla301dml@vip.sina.com

13 sites in 1 country

China13 sites, 13 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

    Chen Zhong, professor, 010-84005219, chenzhong8658@vip.sina.com

    Chen Zhong, professor

    Not yet recruiting

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing

    Zhang Wangde, professor, 010-85231886, drwangde@vip.sina.com

    Zhang Wangde, professor

    Recruiting

  • Beijing Hospital

    Beijing

    Li Yongjun, professor, yongjun.li@foxmail.com

    Li Yongjun, professor

    Recruiting

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing

    Zhang Fuxian, professor, 010-63926252, fuxian@263.net

    Zhang Fuxian, professor

    Recruiting

  • Fuwai Hospital, Chinese Accadamy of Medical Sciences

    Beijing

    Shu Chang, 010-88322377, changshu01@yahoo.com

    Shu Chang, professor

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Huang Jianhua, professor, 0731-84327196, huangjianhua@medmail.com.cn

    Huang Jianhua, professor

    Not yet recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

    Guo Pingfan, professor, 0591-87982072

    Wu Jie, doctor, 13960721962, 13960721962@163.com

    Recruiting

  • Hainan General Hospital

    Haikou, Hainan

    Xiao Zhanxiang, professor, 0898-68622045, xiaozhanxianghn@sina.com

    Xiao Zhanxiang, professor

    Recruiting

  • Longhua Hospital Shanghai University of Tranditional Chinese Medicine

    Shanghai

    Enrolling by invitation

  • Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Jiang Mi'er, professor, 021-23271699-5199, jiangme2013@163.com

    Jiang Mi'er, professor

    Recruiting

  • The First hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Zhang Lei, professor, 0311-85917096, drleizhang@163.com

    Zhang Lei, professor

    Not yet recruiting

  • Tianjin Medical University General Hospital

    Tianjin

    Dai Xiangchen, professor, 022-60362209, 13302165917@163.com

    Dai Xiangchen, professor

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Tian Hongyan, professor, 029-85324128/029-85, tianhhyyxg@163.com

    Tian Hongyan, professor

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
Keywords
drug eluting balloon, Femoral Popliteal Artery
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel Releasing Peripheral Balloon Dilatation CatheterDevice

    Also called LEGFLOW OTW

    in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter

  • Peripheral Balloon Dilatation CatheterDevice

    Also called Admiral Xtreme

    in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter

Study groups in NCT02965677
Study groupRoleWhat they receive
LEGFLOW OTW groupExperimentalin this group subject will be treated by Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) and followed up
Receives: Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
Admiral XtremeActive comparatorin this group subject will be treated by Peripheral Balloon Dilatation Catheter (Admiral Xtreme) and followed up
Receives: Device: Peripheral Balloon Dilatation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinically driven target lesion revascularization (CD-TLR)

    Measured: 12 month post procedure

Secondary outcomes (15)

  1. Procedural Success

    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.

    Measured: at 0-30 days

  2. Device Success

    Device Success defines as the device successfully delivered to the target location, inflated, deflated and withdrawn from the treated balloon inflation tube.

    Measured: at 0-30 days

  3. Clinical Success

    Clinical Success defines as operation success, and without any postoperative complication before discharge (death, lesions limb amputation, target lesion thrombosis or TVR)

    Measured: at 0-30 days

  4. Change in Rutherford classification measured

    Measured: at 0-30 days, 6 months and 12 months post procedure

  5. Change in ABI measure

    Measured: at 0-30 days, 6 months and 12 months post procedure

  6. Walking capacity assessment by Walking Impairment Questionnaire (WIQ)

    Measured: at 0-30 days, 6 months and 12 months post procedure

  7. Walking distance assessment by Six Minute Walk Test (6MWT)

    Measured: 0-30 days, 6 months and 12 months post procedure compared with baseline

  8. Quality of life assessment by EQ5D

    Measured: at 0-30 days, 6 months and 12 months post procedure compared with baseline

  9. Target lesion revascularization (TLR)

    Measured: 0-30 days, 6 months and 12 months post procedure

  10. Target vessel revascularization (TVR)

    Measured: at 0-30 days, 6 months and 12 months post procedure

  11. Thrombus at the target lesion site

    Measured: 0-30 days, 6 months and 12 months post procedure

  12. Target limb amputation rates

    Measured: 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.

    Measured: at 0-30 days, 6 months and 12 months post procedure

  14. Clinical-driven target vessel revascularization (CD-TVR) rates

    Measured: at 0-30 days, 6 months and 12 months post procedure

  15. Clinical-driven target lesion revascularization (CD-TLR) rates

    Measured: at 0-30 days, 6 months and 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2020 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02965677
Sponsor's protocol ID
LEGFLOW-2015-01
Status last verified
Nov 2018
First submitted
7 Nov 2016
Last updated
29 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and Peripheral Balloon Dilatation Catheter in people with Peripheral Arterial Disease, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guo Wei, professor (010-66938349, pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinically driven target lesion revascularization (CD-TLR) (time frame: 12 month post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02965677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.

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