Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Sten… (NCT04982367) | Clinical Trial Compass
UnknownNot Applicable
Acoart SCB SFA: Sirolimus Coated Balloon Catheter in the Treatment of Femoropopliteal Artery Stenosis
China166 participantsStarted 2021-12-08
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
The primary patency rate of target lesion at 12 months post-procedure