Back to resultsComparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
Primary Purpose
Claudication
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long
short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
Sponsored by
About this trial
This is an interventional treatment trial for Claudication
Eligibility 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)
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
long coverage
short spot
Arm Description
Primary long full coverage stenting
primary short spot stenting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Ankle-brachial index, etc
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01359423
Brief Title
Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 26, 2011 (Actual)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
long coverage
Arm Type
Experimental
Arm Description
Primary long full coverage stenting
Arm Title
short spot
Arm Type
Active Comparator
Arm Description
primary short spot stenting
Intervention Type
Drug
Intervention Name(s)
Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.
Intervention Description
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 Outcome Measure Information:
Title
The rate of binary restenosis
Description
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
Time Frame
12months after the index procedure
Secondary Outcome Measure Information:
Title
Ankle-brachial index, etc
Description
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
Time Frame
at 12 months according to the stenting strategy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Primary Long Full Coverage Stenting vs Primary Short Spot Stenting for Long Femoropopliteal Artery Disease.
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