Femoral Artery StenosisNCT03683459
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
A study testing FemFlow Drug-Eluting Peripheral Balloon Catheter in people with Femoral Artery Stenosis and Femoral Artery Occlusion, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 18 sites in China.
Trial summary
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis
- What is being tested?
- FemFlow Drug-Eluting Peripheral Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 18 sitesChina
- Study dates
- 18 Jul 2018to 31 Dec 2022
- 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
- 1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
- 2. Patients with peripheral femoral or popliteal artery stenosis (greater than or equal to 70%) or occlusive disease;
- 3. Rutherford classification graded 2-5；
- 4. The subject or its legal representative can understand the purpose of the study, show sufficient compliance with the test protocol, and sign the informed consent.
Who cannot join
- 1. Patient with arteritis;
- 2. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
- 3. Any cerebrovascular accidents within 3 months；
- 4. Any unstable coronary heart disease or myocardial infarction within 3 months；
- 5. Any important organ failure；
- 6. Any known hypersensitivity to heparin, aspirin, clopidogrel, paclitaxel, paclitaxel compounds and contrast agents;
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- 7. Cannot accept antiplatelet and/or anticoagulation therapy；
- 8. Patients with hemorrhagic physical diseases；
- 9. Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；
- 10. Serum creatinine > 2mg/dl (177umol/L)；
- 11. Pregnant or lactating woman；
- 12. In the absence of intervention, the three lumens of tibialis anterior, tibialis posterior and peroneal artery stenosis or occlusion degree were all >50%；
- 13. iliac artery stenosis >50%, or lumen stenosis >50% after treatment (Limited to non-drug-eluting balloon or stent treatment only)；
- 14. The guide wire cannot pass through target lesions (Passing through target lesions refers to the head of the guidewire arrive beyond the lesion in the absence of interlayer or perforation)；
- 15. Severe calcification at target lesions and should not be treated with balloon dilatation therapy;
- 16. Pre-dilation or anticipated severe vascular dissections after dilation;
- 17. Residual stricture of >50% or severe current-limiting dissection after pre-dilation is not suitable for simple balloon dilatation catheter treatment;
- 18. The total length of target lesions is >200mm, or the reference diameter of the target vessel was >7mm or <3mm;
- 19. Life expectancy is less than one year;
- 20. Participated in clinical trials of other drugs or instruments at the same time;
- 21. Other conditions not suitable for inclusion judged by researchers.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 18 recruiting
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Xiaoming Zhang
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Jianhua Huang
- Not yet recruiting
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan
Chunshui He
- Not yet recruiting
The First People's Hospital of Foshan
Foshan, Guangdong
Canhua Luo
- Recruiting
Hainan General Hospital
Haikou, Hainan
Zhanxiang Xiao
- Not yet recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan
Yaoguang Feng
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Xing Jin
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Xiao Qin
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Guowei Fu, Professor
- Not yet recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
Lefeng Qu
- Not yet recruiting
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xinwu Lu
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Jun Zhao
- Recruiting
Tianjing Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
Xiangchen Dai
- Not yet recruiting
The Central Hospital of Wuhan
Wuhan, Hebei
Tao He
- Not yet recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian
Xiaojin Huang
- Not yet recruiting
Yantai YuHuangDing Hospital
Yantai, Shandong
Mu Yang
- Recruiting
Zhongshang People's Hospital
Zhongshan, Guangdong
Jianhang Miao
About this study
Official title: Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter for Lesions With Femoral-popliteal Artery Stenosis or Occlusion: a Prospective, Multi-centre, Objective Performance Criteria Clinical Trial.
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion.
Read the detailed description
This study is a prospective, multi-centre, single-group target value clinical study. Taking the patency rate at 12 months after operation as the primary evaluation index and taking target vascular cavity loss rate at 6 months postoperatively, Rutherford Classification at 12 months postoperatively, the ankle/brachial index (ABI), revascularization rate of target lesions, revascularization rate of target vessels, operating success rate and success rate of surgery as the secondary evaluation indexes to evaluate the efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion. Taking the incidence of major adverse events (MAE), adverse events (AE) and instrument defects occurred through the entire trail as the evaluation indexes to evaluate the safety of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Company for lesions with femoropopliteal artery stenosis or occlusion. According to statistical hypothesis and sample size calculation, the sample size of this clinical trial was 208 cases. All subjects were followed up 1 month, 6 months and 12 months after treatment with a FemFlow Drug-Eluting Peripheral Balloon Catheter, and data on efficacy and safety were collected. All relevant clinical data are managed and analyzed by the professional data management centre and the statistical centre. End-point events of clinical trials are determined by a specially established third party.
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
- Being tested
- FemFlow Drug-Eluting Peripheral Balloon Catheter
- Keywords
- FemFlow, Drug-eluting peripheral balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemFlow Drug-Eluting Peripheral Balloon CatheterDevice
Medical devices will be applied to the enrolled subjects. The arterial pathway was established, followed by lower limb arteriography, and the auxiliary equipment was selected according to the stenosis of the subject's target lesions, followed by pre-dilation. Patients with residual stenosis ≤70% after pre-dilation and suitable for simple balloon dilation catheter treatment can be enrolled. Select the appropriate size of the experimental drug balloon for expansion, then radiography was used to observe the expansion effect, if necessary, multiple expansion can be conducted, and finally withdraw the instrument and suture the puncture point.
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | Participants will be treated with FemFlow Drug-Eluting Peripheral Balloon Catheter. Receives: Device: FemFlow Drug-Eluting Peripheral Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate of the first phase
Target vessel patency is defined as all target lesion lumen stenosis of the target vessel ≤50%. Doppler ultrasonography showed that the peak systolic velocity ratio (PSVR) was ≤ 2.4, which could be considered as the target lesion stenosis ≤50%.
Measured: Postoperative 30 ± 7days
Secondary outcomes (7)
Target vascular cavity loss rate.
Target vascular cavity loss rate (LLL) is defined as the value of the minimum diameter reduction in the segment of target lesions after surgery. Evaluation was performed by lower limb artery digital subtraction angiography (DSA) examination.
Measured: Postoperative 180 ± 28days
Rutherford Classification.
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Measured: Postoperative 30 ± 7days
Ankle/brachial index (ABI)
The ankle/brachial index (ABI) is defined as the systolic pressure ratio of the tibialis posterior artery or tibialis anterior artery of the affected limb to the ipsilateral brachial artery when the subject is lying flat.
Measured: Postoperative 30 ± 7days
Revascularization rate of target lesions
Target lesion revascularization was defined as finding target lesion embolism or restenosis (stenosis in diameter of >50%) during follow-up, and additional intervention was required according to clinical symptoms.
Measured: Postoperative 30 ± 7days
Revascularization rate of target vessels
Target lesion revascularization was defined as finding target vessels embolism or restenosis (stenosis in diameter of >50%) during follow-up, and additional intervention was required according to clinical symptoms.
Measured: Postoperative 30 ± 7days
Operating success rate
Successful operation is defined as in the course of operation, the peripheral balloon catheter can reach the location of the disease and successfully expand, fail to rupture the balloon, and successfully withdraw.
Measured: Intraoperative
Success rate of surgery
The success of surgery is defined as the residual stenosis rate ≤30% during the operation.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start18 Jul 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery StenosisStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guowei Fu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683459
- Sponsor's protocol ID
- DEB-01
- Status last verified
- Feb 2020
- First submitted
- 20 Sep 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter for Lesions With Femoral-popliteal Artery Stenosis or Occlusion: a Prospective, Multi-centre, Objective Performance Criteria Clinical Trial.
- ClinicalTrials.gov ID
- NCT03683459
- Acronym / sponsor ID
- DEB-01
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
- Keywords
- FemFlow, Drug-eluting peripheral balloon catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Sep 2018 (actual)
- 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.
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion.
Detailed description
This study is a prospective, multi-centre, single-group target value clinical study. Taking the patency rate at 12 months after operation as the primary evaluation index and taking target vascular cavity loss rate at 6 months postoperatively, Rutherford Classification at 12 months postoperatively, the ankle/brachial index (ABI), revascularization rate of target lesions, revascularization rate of target vessels, operating success rate and success rate of surgery as the secondary evaluation indexes to evaluate the efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion. Taking the incidence of major adverse events (MAE), adverse events (AE) and instrument defects occurred through the entire trail as the evaluation indexes to evaluate the safety of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Company for lesions with femoropopliteal artery stenosis or occlusion. According to statistical hypothesis and sample size calculation, the sample size of this clinical trial was 208 cases. All subjects were followed up 1 month, 6 months and 12 months after treatment with a FemFlow Drug-Eluting Peripheral Balloon Catheter, and data on efficacy and safety were collected. All relevant clinical data are managed and analyzed by the professional data management centre and the statistical centre. End-point events of clinical trials are determined by a specially established third party.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Device: FemFlow Drug-Eluting Peripheral Balloon CatheterParticipants will be treated with FemFlow Drug-Eluting Peripheral Balloon Catheter. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
- 2. Patients with peripheral femoral or popliteal artery stenosis (greater than or equal to 70%) or occlusive disease;
- 3. Rutherford classification graded 2-5；
- 4. The subject or its legal representative can understand the purpose of the study, show sufficient compliance with the test protocol, and sign the informed consent.
Key exclusion criteria (21 listed)
- 1. Patient with arteritis;
- 2. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
- 3. Any cerebrovascular accidents within 3 months；
- 4. Any unstable coronary heart disease or myocardial infarction within 3 months；
- 5. Any important organ failure；
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 |
|---|---|---|
| FemFlow Drug-Eluting Peripheral Balloon CatheterMedical devices will be applied to the enrolled subjects. The arterial pathway was established, followed by lower limb arteriography, and the auxiliary equipment was selected according to the stenosis of the subject's target lesions, followed by pre-dilation. Patients with residual stenosis ≤70% after pre-dilation and suitable for simple balloon dilation catheter treatment can be enrolled. Select the appropriate size of the experimental drug balloon for expansion, then radiography was used to observe the expansion effect, if necessary, multiple expansion can be conducted, and finally withdraw the instrument and suture the puncture point. | Device | interventional arm |
Primary outcome
Patency rate of the first phase
Time frame: Postoperative 30 ± 7days
Target vessel patency is defined as all target lesion lumen stenosis of the target vessel ≤50%. Doppler ultrasonography showed that the peak systolic velocity ratio (PSVR) was ≤ 2.4, which could be considered as the target lesion stenosis ≤50%.
7 secondary outcomes
Target vascular cavity loss rate.
Time frame: Postoperative 180 ± 28days
Rutherford Classification.
Time frame: Postoperative 30 ± 7days
Ankle/brachial index (ABI)
Time frame: Postoperative 30 ± 7days
Revascularization rate of target lesions
Time frame: Postoperative 30 ± 7days
Revascularization rate of target vessels
Time frame: Postoperative 30 ± 7days
Operating success rate
Time frame: Intraoperative
Success rate of surgery
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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SELUTION4SFA Trial
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First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
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Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
Aortic Stenosis
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A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
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.
Guowei Fu principal investigator
Fudan University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemFlow Drug-Eluting Peripheral Balloon Catheter in people with Femoral Artery Stenosis and Femoral Artery Occlusion, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 18 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 4 inclusion and 21 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 Ying Xia (+86 13760184511, xiaying@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate of the first phase (time frame: Postoperative 30 ± 7days). 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 5 Feb 2020.