A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFrontAce Scientific Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
Patients with serum creatinine >2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
Severe coagulation disorder;
Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);
Trial design
Treatments tested in this trial
- Sperstent® peripheral spot stent system
- Everflex® self-expanding peripheral stent system
Treatment groups
240 Participants
are divided into 2 treatment groupsLocations
12Beijing Friendship Hospital, Capital Medical University BeijingBeijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University ChongqingChongqing Municipality, China
The Second Hospital of Hebei Medical University ShijiazhuangHebei, China
First Affiliated Hospital of Zhengzhou University ZhengzhouHenan, China
Sponsors and collaborators
FrontAce Scientific Co., Ltd
Lead sponsor
Source ClinicalTrials.gov