NCT01359423

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Claudication

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2011-09-26
• Primary completion: 2017-08-10
• Completion: 2017-08-10
• First posted: 2011-05-24
• Last updated: 2017-11-28

Locations

1 site across 1 country: South Korea