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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography(DSA)
Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography(DSA)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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)
Time frame: 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.
Time frame: 30 days post-operation
Rate of Device Success
Defined as successful delivery, release and retrieval of the device.
Time frame: 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.
Time frame: 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)
Time frame: 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.
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The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGLiyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGNanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGAffiliated Hospital of Nantong University
Nantong, Jiangsu, China
NOT_YET_RECRUITINGRenji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
NOT_YET_RECRUITING...and 2 more locations
Time frame: 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).
Time frame: 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.
Time frame: 30 days, 6 months and 12 months post-operation
Duplex Ultrasound (DUS) Derived Lesion Patency
Lesion Patency is evaluated by Duplex Ultrasound (DUS)
Time frame: 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) .
Time frame: 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.
Time frame: 12 months post-operation