An interventional study of FemFlow Drug-Eluting Peripheral Balloon Catheter in Femoral Artery Stenosis, Femoral Artery Occlusion and Popliteal Arterial Stenosis, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Status unknown at 18 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. · Not applicable, Interventional, and Treatment
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.
296 studies on the registry are indexed under Arterial Occlusive Diseases; 46 are open to participants now.
This study's planned enrollment of 208 is above the median of 121 across 200 interventional studies indexed under Arterial Occlusive Diseases.
Browse Arterial Occlusive Diseases studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
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Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
Exclusion Criteria:
Patient with arteritis;
Participants will be treated with FemFlow Drug-Eluting Peripheral Balloon Catheter.
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.
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%.
Time frame: Postoperative 30 ± 7days
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative
Success rate of surgery
The success of surgery is defined as the residual stenosis rate ≤30% during the operation.
Time frame: Intraoperative
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Lifetech Scientific (Shenzhen) Co., Ltd.