Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
NCT ID: NCT01359423
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
89 participants
INTERVENTIONAL
2011-09-26
2017-08-10
Brief Summary
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Study design :
* Prospective, randomized, multi-center study
* A total of 220 subjects with symptomatic peripheral artery disease of lower limbs who meet all inclusion and exclusion criteria will be included.
* Patients will be randomized in a two by two factorial manner according to the strategy of stenting (long versus short stenting) and the additional use of cilostazol. Each randomization of the enrolled subjects will be done 1:1.
* Patients will be followed clinically for 1 year after the procedure.
* Angiographic or CT follow-up will be performed at 1 year.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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long coverage
Primary long full coverage stenting
Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
short spot
primary short spot stenting
short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Interventions
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Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
Eligibility Criteria
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Inclusion Criteria
1. Age 20 years of older
2. Symptomatic peripheral artery disease:
* Moderate or severe claudication (Rutherford category 2 or 3)
* Critical limb ischemia (Rutherford category 4 or 5)
3. Patients with signed informed consent
Anatomical criteria:
1. Target lesion length ≥80 mm by angiographic estimation
2. Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery
3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.
Exclusion Criteria
1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Major bleeding history within prior 2 months
4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
5. Age \> 85 years
6. Severe hepatic dysfunction (\> 3 times normal reference values)
7. Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
Angiographic criteria
1. Previous bypass surgery or stenting of the superficial femoral artery
2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
20 Years
79 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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1-2010-0065
Identifier Type: -
Identifier Source: org_study_id