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

Not Applicable

Completed

• Conditions: Claudication
• Interventions: 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.

• Registration Number: NCT01359423
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-24
• Study Start: 2011-09-26
• Primary Completion: 2017-08-10
• Study Completion: 2017-08-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long coverage	Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long	Primary long full coverage stenting
short spot	short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.	primary short spot stenting

Primary Outcome Measures

Name	Time	Method
The rate of binary restenosis	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

Secondary Outcome Measures

Name	Time	Method
Ankle-brachial index, etc	at 12 months according to the stenting strategy	1. Ankle-brachial index at 12 months according to the stenting strategy; 2. Maximal walking distance at 12 months according to the stenting strategy; 3. The rate of reintervention including repeat endovascular therapy or bypass surgery involving the target lesion; 4. The rate of limb salvage at 12 months according to the stenting strategy; 5. The rate of major adverse cardiovascular events (MACE) at 12 months according to the stenting strategy

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of