Peripheral Artery DiseaseNCT02962232
A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW
A study testing Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and PTA catheter in people with Peripheral Artery Disease, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and PTA catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 19 sitesChina
- Study dates
- Nov 2016to Dec 2020
- 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 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;
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- 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
19 sites in 1 country.
Chen zhong, professor contact
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Beijing Anzhen Hospital Capital Medical University
Beijing
zhong Chen, chenzhong8658@vip.sina.com
- Recruiting
Beijing Chao-Yang Hospital
Beijing
Zhang wangde, professor, drwangde@vip.sina.com
Zhang wangde, professor
- Recruiting
Beijing Frendship Hospital, Capital Medical University
Beijing
Chen xueming, professor, chenxueming04@sohu.com
Chen xueming, professor
- Recruiting
Beijing Hospital
Beijing
Li Yongjun, professor, yongjun.li@foxmail.com
Li Yongjun, professor
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing
Luo Xiaoyun, A. professor, paperWord@vip.163.com
Luo Xiaoyun, A. professor
- Recruiting
Chinese PLA General Hospital
Beijing
Guo wei, professor, pla301dml@vip.sina.com
Guo wei, professor
- Recruiting
Fuwai Hospital, Chinese Accadamy of Medical Sciences
Beijing
Shu Chang, professor, changshu@yahoo.com
Shu Chang, professor
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Huang jianhua, professor, huangjianhua@medmail.com.cn
Huang jianhua, professor
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Zhao, xgwkzjc@163.com
Jichun
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Guo pingfan, professor, 13960721962@163.com
Guo pingfan, professor
- Recruiting
Hainan General Hospital
Haikou, Hainan
Xiao Zhanxiang, professor
xiaozhanxianghn@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Zhou weimin, professor, drzwm@sina.com
Zhou weimin, professor
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Zhang Xiwei, professor, xiwei1092@163.com
Zhang Xiwei, professor
- Not yet recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Zhang Lan, professor, lucky200207@aliyun.com
Zhang Lan, professor
- Recruiting
Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Jiang mi'er, professor, jiangme2013@163.com
Jiang mi'er, professor
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei
Shi xiaoming, a. professor, shixiaoming1999@126.com
Shi xiaoming, a.professor
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zhang Lei, professor, drleizhang@163.com
Zhang Lei, professor
- Recruiting
Tianjing Medical University General Hospital
Tianjin
Dai xiangchen, professor, 13302165917@163.com
Dai xiangchen, professor
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Tian Hongyan, professor, tianhhyyxg@163.com
Tian Hongyan, professor
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, PTA catheter
- Keywords
- drug eluting balloon, arterial vasculature below the knee
- 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
treatment group
PTA catheterDevice
Also called AMPHIRION DEEP
control group
| Study group | Role | What they receive |
|---|---|---|
| LEGFLOW OTW group | Experimental | in the LEGFLOW OTW group the subject will be treated by the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) Receives: Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter |
| AMPHIRION DEEP group | Active comparator | in the AMPHIRION DEEP group the subject will be treated by PTA catheter (AMPHIRION DEEP) Receives: Device: PTA catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion restenosis determined by CTA
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).
Measured: 6 month post procedure
Secondary outcomes (9)
device success rate
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
operation success rate
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.
Measured: at 0-30 days
clinical success rate
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
change of the Rutherford score
Measured: in day 0-30, 6th month, 12th month post operation
change of the life equality by EQ5D
Measured: in day 0-30, 6th month, 12th month post operation compares to baseline
target limb ulcer healing rate
healing or not, if not: improve, no change, or progression;
Measured: in day 0-30, 6th month, 12th month post operation
target lesion revascularization rate
Measured: in day 0-30, 6th month, 12th month post operation
target limb upper amputation and lower amputation rate
Measured: 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
Measured: in day 0-30, 6th month, 12th month post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen zhong, professor, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962232
- Sponsor's protocol ID
- LEGFLOW-2015-02
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02962232
- Acronym / sponsor ID
- LEGFLOW-2015-02
- Conditions
- Peripheral Artery Disease
- Keywords
- drug eluting balloon, arterial vasculature below the knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEGFLOW OTW group | Experimental | Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheterin the LEGFLOW OTW group the subject will be treated by the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) |
| AMPHIRION DEEP group | Active comparator | Device: PTA catheterin the AMPHIRION DEEP group the subject will be treated by PTA catheter (AMPHIRION DEEP) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- reference vessel diameter 2.0-3.5mm;
Key exclusion criteria (23 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel Releasing Peripheral Balloon Dilatation CatheterAlso: LEGFLOW OTWtreatment group | Device | LEGFLOW OTW group |
| PTA catheterAlso: AMPHIRION DEEPcontrol group | Device | AMPHIRION DEEP group |
Primary outcome
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).
9 secondary outcomes
device success rate
Time frame: at 0-30 days
operation success rate
Time frame: at 0-30 days
clinical success rate
Time frame: at 0-30 days
change of the Rutherford score
Time frame: 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
target limb ulcer healing rate
Time frame: 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
target limb upper amputation and lower amputation rate
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen zhong, professor contact
Chen zhong, professor principal investigator
Beijing Anzhen Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and PTA catheter in people with Peripheral Artery Disease, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 19 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 12 inclusion and 23 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 19 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 Chen zhong, professor (chenzhong8658@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion restenosis determined by CTA (time frame: 6 month post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.