Peripheral Arterial Disease
Conditions
Keywords
Femoropopliteal lesions, Patency
Brief summary
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
Detailed description
One hundred twenty patients with lesion lengths longer than 15 cm will be included. Patients will be invited for a follow-up visit at 1, 6, 12, and 24-month post-procedure. The primary effectiveness endpoint of the study is the primary patency at 12 months. The primary safety endpoint is freedom of major adverse events (MAEs) at 12 months. Secondary endpoints include acute procedure success rate; primary patency rate at 1, 6, and 24 months; freedom from TLR at 1-, 6-, 12, and 24-month follow-up; primary and secondary sustained clinical improvements at 1-, 6-, 12- and 24-month follow-up; Freedom of MAEs at 1-, 6-,12- and 24- month follow-up; change of quality of life at 1-, 6-,12- and 24- month follow-up.
Interventions
DEVICESmart flex stent
Smart flex stent will be used for femoropopliteal occlusive lesions.
Sponsors
Xuanwu Hospital, Beijing
Second Affiliated Hospital of Soochow University
First Affiliated Hospital of Zhejiang University
First People's Hospital of Hangzhou
Qingdao Haici Hospital
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Fudan University
Dongfang Hospital Beijing University of Chinese Medicine
Xiamen Cardiovascular Hospital, Xiamen University
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient presented a score from 2 to 5 following Rutherford classification 2. The patient is willing to comply with specified follow-up evaluations at the specified times 3. The patient is \>18 years old 4. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study 5. The patient has a projected life expectancy of at least 24 months 6. Before enrolment, the guidewire has crossed the target lesion 7. Target lesion length ≧150mm by angiographic estimation 8. Stenosis \> 50% or occlusion in the femoropopliteal artery 9. There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot
Exclusion criteria
1. Previous bypass surgery or stenting in the target vessel 2. Patients who exhibit acute intraluminal thrombus at the target lesion vessel 3. Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy 4. Pregnant women or Female patients with potential childbearing 5. Use of thrombectomy, atherectomy, or laser devices during the procedure 6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion 7. The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. 8. Significant renal dysfunction (Serum creatinine \>2.0mg/dl) 9. Patient with Known allergy to contrast media
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12-month | Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5). |
| Freedom of major adverse events (MAEs) | 12-month | Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from clinically directed target lesion revascularization | 24-month | Patients without clinically directed target lesion revascularization |
| Freedom of major adverse events (MAEs) | 24-month | Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death. |
| Acute procedure success | 72-hour within procedure | Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis \<30% for stent and \<50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient \<10 mm Hg for endovascular revascularization ) and freedom form major adverse events. |
| Vasc quality of life score | 24-month | Change of Vasc quality of life |
| Primary sustained clinical improvement | 24-month | Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation. |
| Primary patency | 24-month | Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5). |
Countries
China
Contacts
Primary ContactNi Qihong, M.D.
Outcome results
None listed