Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter

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.

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.

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.