NCT03683459

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Artery Stenosis
• Femoral Artery Occlusion
• Popliteal Arterial Stenosis
• Popliteal Artery Occlusion

Interventions

Type	Name	Description
DEVICE	FemFlow Drug-Eluting Peripheral Balloon Catheter	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.

Timeline

• Start date: 2018-07-18
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-09-25
• Last updated: 2020-02-05

Locations

18 sites across 1 country: China