Atherosclerosis Clinical Trial
— SENS-FPOfficial title:
Efficacy of Self-Expanding Nitinol S.M.A.R.T-CONTROL Stent Versus Complete SE Stent For The Atherosclerotic Femoro-Popliteal Arterial Disease : Prospective, Multicenter, Randomized, Controlled Trial (SENS-FP Trial)
Verified date | March 2018 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Recent stent design improvements focus on decreasing stent fracture rates which can negatively impact patency rates by rearranging strut alignment. Although there have been several retrospective or registry studies for atherosclerotic femoropopliteal disease in the East, there have been few randomized control trial for comparison of stent fracture and primary patency between different nitinol stents. Smart stent has the peak-to-valley bridge and in-line interconnection. Medtronics company have claimed Complete's stent crowns have been configured to minimize crown to crown interaction, increasing the stent's flexibility without compromising radial strength. We made the hypothesis that the design of Complete-SE stent might be more fracture-resistant or effective for in-stent restenosis, compared with Smart stent. On the other hand, 2011 ESC guideline recommended that dual antiplatelet therapy with aspirin and a thienopyridine for at least one month is recommended after infrainguinal bare-metal-stent implantation. Recent meta-analysis has shown that the efficacy of cilostazol in the atherosclerotic femoropopliteal lesion was proven. However, still specific data regarding a variety of antiplatelet regimen are limited. To date, there is no the study for comparison between clopidogrel and cilostazole in patient undergone stent implantation in femoropopliteal lesion. In conclusion, the purpose of our study is to examine and compare Primary patency and stent fracture between different two-nitinol stents (S.M.A.R.T. CONTROL versus Complete SE) and to compare binary restenosis rate between clopidogrel and cilostazol in femoropopliteal arterial lesion.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Clinical criteria 1. Age 20 years of older 2. Symptomatic peripheral-artery disease with (Rutherford 2 - 6); moderate to severe claudication (Rutherford 2-3), chronic critical limb ischemia with pain while was at rest (Rutherford 4), or with ischemic ulcers (Rutherford 5-6) 3. Patients with signed informed consent - Anatomical criteria 1. Stenosis of >50% or occlusive atherosclerotic lesion of the ipsilateral femoropopliteal artery 2. Patent (=50% stenosis) ipsilateral iliac artery or concomitantly treatable ipsilateral iliac lesions (=30% residual stenosis), 3. At least one patent (less than 50% stenosed) tibioperoneal run-off vessel. Exclusion Criteria: 1. Disagree with written informed consent 2. Major bleeding history within prior 2 months 3. Known hypersensitivity or contraindication to any of the following medication: heparin, aspirin, clopidogrel, cilostazol, or contrast agent 4. Acute limb ischemia 5. Previous bypass surgery or stenting of the ipsilateral femoropopliteal artery 6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion) 7. Patients that major amputation ("above the ankle" amputation) has been done, is planned or required 8. Patients with life expectancy <1 year due to comorbidity |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Cardiovascular center, Korea University Guro Hospital | Seoul | |
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of binary restenosis | the rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) or PSVR = 2.5 or zero (PSVR=peak systolic velocity within the area of stenosis divided by peak systolic velocity in a normal adjacent proximal artery segment) in the treated segment at 12 months after intervention as determined by catheter angiography or Duplex ultrasound | one year | |
Secondary | stent fracture rate, clinical outcomes, angiographic outcomes, ankle-brachial index | stent fracture rate according to fracture grade (minor, moderate, severe Limb salvage rate free of above-the-ankle amputation Sustained clinical improvement rate at 12 month follow-up Repeated target lesion revascularization (TLR) rate Repeated target extremity revascularization (TER) rate Total re-occlusion rate Comparison of angiographic variables consisted of late loss and % restenosis Ankle-brachial index (ABI) at 12 months The rate of major adverse cardiovascular events (MACE) composed of all-cause death, myocardial infarction, and stroke at 12 months Incidence of geographic miss during stent deployment due to jumping and elongation The rate of binary restenosis or PSVR = 2.5 or zero according to clopidogrel and cilostazol Major bleeding rate between clopidogrel and cilostazol group. |
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