A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries (NCT06539689) | Clinical Trial Compass
RecruitingNot Applicable
A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
China240 participantsStarted 2024-06-04
Plain-language summary
This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.
Who can participate
Age range18 Years – 85 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 18-85 years old, male or female;
* The target lesion is located in the superficial femoral artery or the proximal popliteal artery;
* Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5;
* Estimated life expectancy \>1 year;
* Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
Angiographic Inclusion Criteria:
* Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate);
* Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one limb meeting the protocol criteria is selected by the investigator; More than 2cm between lesions are considered as 2 lesions);
* After PTA treatment by DCB, there exists residual lesions, such as the target lesion has over 30% residual DS and/or presence of at least one post-PTA dissection (Type A-F) (by visual estimate);
* Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤50%;
* Angiography showed at least one outflow tract was unobstructed at the distal end (Stenosis degree ≤70% before intervention).
Exclusion Criteria:
* Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
* Patients wit…