Clinical trial NCT05246410: A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
Official title: A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Vascular Disease (PVD)
Peripheral Arterial Disease (PAD)
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.

Detailed description: The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old and ≤80 years old
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
* Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
* Presence of at least one patent infrapopliteal vessel.
* The length of target lesion ≥10 cm.
* After predilation, the target lesion has \<30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
* Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed.

Exclusion Criteria:

* The plasma creatinine level is higher than 150 umol/L.
* Thrombolysis or thrombectomy is required.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* Previously implanted stent in the target lesion.
* The guide wire can not cross the target lesion.
* Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
* Patient has a known allergy to anticoagulant drugs, anti-platelet drugs or contrast medium that cannot be adequately pre-medicated.
* Women who are pregnant or breast-feeding.
* The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
* Patient has life expectancy of less than 12 months.
* Patient who planned to do above the ankle amputation before the operation.
* Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
* The investigator think the patient is not suitable for participation in the clinical trial.

Primary outcomes:
measure: The primary patency rate of target lesion at 12 months post-procedure
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Rate of device success
timeFrame: immediate post-procedure
measure: Rate of procedural success
timeFrame: 7 days post-procedure
measure: Rate of clinically driven target lesion revascularization within 12 months post-procedure
timeFrame: 12 months post-procedure
measure: The change of Rutherford class from baseline
timeFrame: 12 months post-procedure
measure: The change of ankle-brachial index (ABI) from baseline
timeFrame: 12 months post-procedure
measure: Rate of composite safety endpoint
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Zhejiang
country: China
facility: Zhejiang Provincial People'S Hospital
state: Zhejiang
Study officials:
affiliation: Chinese PLA General Hospital
name: Guo Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: