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

NCT01359423 | Completed DMC

• 1 other identifier: 1-2010-0065
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Claudication

Outcome Measures

Primary Outcomes (1)

• The rate of binary restenosis

  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

  12months after the index procedure

Secondary Outcomes (1)

• Ankle-brachial index, etc

  at 12 months according to the stenting strategy

Study Arms (2)

long coverage

EXPERIMENTAL

Primary long full coverage stenting

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

short spot

ACTIVE COMPARATOR

primary short spot stenting

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

Interventions

Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long DRUG

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.

long coverage

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

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

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant women or women with potential childbearing
• Life expectancy \<1 year due to comorbidity
• Angiographic criteria
• Previous bypass surgery or stenting of the superficial femoral artery
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: September 26, 2011
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

KR (1)