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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sperstent® peripheral spot stent system | Experimental | subjects using the Sperstent® peripheral spot stent system |
|
| Everflex® self-expanding peripheral stent system | Active Comparator | subjects using the Everflex® self-expanding peripheral stent system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sperstent® peripheral spot stent system | Device | Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography(DSA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Zhou, Dr. | Contact | 01186-25-83106666 | 60770 | zhouminnju@126.com |
| Xiang Wang, Dr. | Contact | 01186-21-38804518 | 22265 | vascular_doc@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Everflex® self-expanding peripheral stent system | Device | Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography(DSA) |
|
| 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 |
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
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| Liyuan Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | China |
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| Affiliated Hospital of Nantong University | Not yet recruiting | Nantong | Jiangsu | China |
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| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Hospital of Chengdu University of TCM | Not yet recruiting | Chengdu | China |
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| Shanghai East Hospital | Recruiting | Shanghai | China |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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