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

Purpose

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.

Condition	Intervention
Claudication	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
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Rashes

Drug Information available for: Cilostazol

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

The rate of binary restenosis [ Time Frame: 12months after the index procedure ] [ Designated as safety issue: No ]
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:

Ankle-brachial index, etc [ Time Frame: at 12 months according to the stenting strategy ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	220
Study Start Date:	March 2011
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: long coverage Primary long full coverage stenting	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.
Active Comparator: short spot primary short spot stenting	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.

Arms

Assigned Interventions

Experimental: long coverage

Primary long full coverage stenting

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.

Active Comparator: short spot

primary short spot stenting

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.

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359423

Contacts

Contact: Donghoon Choi

2-2228-8460

chdljy@yuhs.ac

Locations

Korea, Republic of
Severance Hospital	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Donghoon Choi 82-2-2228-8460 cdhljy@yuhs.ac

Sponsors and Collaborators

Yonsei University

More Information

No publications provided

Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01359423 History of Changes
Other Study ID Numbers:	1-2010-0065
Study First Received:	May 20, 2011
Last Updated:	January 31, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents

Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 19, 2013