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OpenTrials
Completed

NCT Number: NCT01359423

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

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.

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Key information

Conditions

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

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Ankle-brachial index, etc

    Time frame: at 12 months according to the stenting strategy

    • Ankle-brachial index at 12 months according to the stenting strategy
    • Maximal walking distance at 12 months according to the stenting strategy
    • The rate of reintervention including repeat endovascular therapy or bypass surgery involving the target lesion
    • The rate of limb salvage at 12 months according to the stenting strategy
    • The rate of major adverse cardiovascular events (MACE) at 12 months according to the stenting strategy

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 24, 2011
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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