A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
NCT Number: NCT06539689
Acronym: SURF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Arterial Disease|Stenosis|Dissection
Interventions: DEVICE: Sperstent® peripheral spot stent system|DEVICE: Everflex® self-expanding peripheral stent system
Sponsor: FrontAce Scientific Co., Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-04
Completion Date: 2026-12-31
Locations: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, China|The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China|The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China|First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China|Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China|Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China|Affiliated Hospital of Nantong University, Nantong, Jiangsu, China|Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China|The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China|The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China|Hospital of Chengdu University of TCM, Chengdu, China|Shanghai East Hospital, Shanghai, China

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.

Primary Outcome Measures: Primary Patency, Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR \>2.5), 12 months post-operation|Freedom from Major Adverse Events (MAEs), Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation., 30 days post-operation
Secondary Outcome Measures: Rate of Device Success, Defined as successful delivery, release and retrieval of the device., immediately post-operation|Rate of Procedural Success, Demonstrated vessel patency (\<30% residual DS, by visual estimate) without the use of a bailout stent or the occurrence of MAE upon completion of the index procedure., immediately post-operation|Primary Patency at 30 days and 6 months, defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 30 days and 6 months post-operation (defined as PSVR \>2.5), 30 days and 6 months post-operation|Rate of clinically driven target lesion revascularization (CD-TLR), Clinically driven target lesion revascularization (CD-TLR) was defined as an endovascular reintervention performed for a \>50% diameter stenosis of the target vessel in the presence of a recurrent PAD symptom after the initial endovascular procedure., 30 days, 6 months and 12 months post-operation|Changes from Baseline in Rutherford Classification, Defined as change in target limb Rutherford class from baseline. Rutherford Classification is defined as follows, with increasing severity:

Rutherford Category 0 - Asymptomatic. Rutherford Category 1 - Mild Claudication. Rutherford Category 2 - Moderate Claudication. Rutherford Category 3 - Severe Claudication. Rutherford Category 4 - Ischemic Rest Pain. Rutherford Category 5 - Minor Tissue Loss (minor exertion). Rutherford Category 6 - Major Tissue Loss (gangrene)., 30 days, 6 months and 12 months post-operation|Changes from Baseline in Ankle-brachial Index (ABI), Defined as change of target limb ABI from baseline. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm., 30 days, 6 months and 12 months post-operation|Duplex Ultrasound (DUS) Derived Lesion Patency, Lesion Patency is evaluated by Duplex Ultrasound (DUS), 30 days, 6 months and 12 months post-operation|Rate of major adverse event(s) (MAEs), MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) ., 6 months and 12 months post-operation|Rate of Stent Fracture, Stent fractures will be analyzed by X-ray at 12 months post-operation. The stents implanted into a certain subject will be analyzed collectively in the assessment. Stent fractures will be assessed with Grade I, II, III or IV as follow.

Grade I - a single strut fracture only. Grade II - multiple single strut fractures that occur at different sites of a stent or different stents.

Grade III - multiple nitinol stent fractures resulting in complete transverse linear fracture.

Grade IV - a spiral dissection of a stent. Fractures of Grade I are least severe, increasing in severity to Grade IV., 12 months post-operation