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 groupsSponsors and collaborators
Source ClinicalTrials.gov