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

Yonsei University

Status: Completed

Conditions: Claudication

Treatments: Drug: Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long; Drug: short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.

Study type: Interventional

Funder types: Other

Identifiers

NCT01359423

1-2010-0065

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinical 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

Clinical 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

long coverage

Experimental group

Description:

Primary long full coverage stenting

Treatment:

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

short spot

Active Comparator group

Description:

primary short spot stenting

Treatment:

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