Clinical trial NCT03683459: Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Artery Stenosis
Femoral Artery Occlusion
Popliteal Arterial Stenosis
Popliteal Artery Occlusion
Keywords: FemFlow
Drug-eluting peripheral balloon catheter
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

  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.

Primary outcomes:
measure: Patency rate of the first phase
timeFrame: Postoperative 30 ± 7days
Secondary outcomes:
measure: Target vascular cavity loss rate.
timeFrame: Postoperative 180 ± 28days
measure: Rutherford Classification.
timeFrame: Postoperative 30 ± 7days
measure: Ankle/brachial index (ABI)
timeFrame: Postoperative 30 ± 7days
measure: Revascularization rate of target lesions
timeFrame: Postoperative 30 ± 7days
measure: Revascularization rate of target vessels
timeFrame: Postoperative 30 ± 7days
measure: Operating success rate
timeFrame: Intraoperative
measure: Success rate of surgery
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Foshan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshang People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hebei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai YuHuangDing Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Tianjin
country: China
facility: Tianjing Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Fudan University
name: Guowei Fu
role: PRINCIPAL_INVESTIGATOR
References: