Clinical trial NCT04982367: Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
Official title: A Prospective, Multicenter, Randomized Controlled Trial Comparing the Efficacy and Safety Between Sirolimus Coated Balloon Catheter and Paclitaxel Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Drug eluting balloon catheter
Peripheral Artery Disease
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 166
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 Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old and ≤80 years old
* Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
* SFA and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion.
* The length of target lesion less than 20 cm
* 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
* There are more than 2 lesion need to treat in the target vessel.
* The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
* The target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation.
* The patient had outflow less than 1 vessel
* The lesion located in a stent.
* Patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus 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.
* 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 clinically driven target lesion revascularization (CD-TLR) at 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
Study officials:
affiliation: Chinese PLA General Hospital
name: Guo Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: