Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.

Yonsei University1 site in 1 country89 target enrollmentSeptember 26, 2011

InterventionsPercutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.

DrugsPercutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.

Overview

Phase: Not Applicable
Intervention: Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long
Conditions: Claudication
Sponsor: Yonsei University
Enrollment: 89
Locations: 1
Primary Endpoint: The rate of binary restenosis
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Hypothesis: Primary long full coverage stenting is superior to primary short spot stenting in the treatment of long (≥80 mm) femoropopliteal artery lesions.

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.

Registry

clinicaltrials.gov

Start Date

September 26, 2011

End Date

August 10, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical criteria:
•Age 20 years of older
•Symptomatic peripheral artery disease:
•Moderate or severe claudication (Rutherford category 2 or 3)
•Critical limb ischemia (Rutherford category 4 or 5)
•Patients with signed informed consent
•Anatomical criteria:
•Target lesion length ≥80 mm by angiographic estimation
•Stenosis of more than 50 percent or occlusion of the ipsilateral superficial femoral artery
•At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

Exclusion Criteria

•Clinical criteria
•Acute critical limb ischemia
•Severe critical limb ischemia (Rutherford category 6)
•Major bleeding history within prior 2 months
•Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
•Age \> 85 years
•Severe hepatic dysfunction (\> 3 times normal reference values)
•Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl
•Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
•LVEF \< 40% or clinically overt congestive heart failure

Arms & Interventions

long coverage

Primary long full coverage stenting

Intervention: Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long

short spot

primary short spot stenting

Intervention: short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.

Outcomes

Primary Outcomes

The rate of binary restenosis

Time Frame: 12months after the index procedure

The rate of binary restenosis (stenosis of at least 50 percent of the luminal diameter) in the treated segment 12 months after intervention, as determined by computed tomographic angiography (CTA) or catheter angiography according to the stenting strategy