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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long coverage | Experimental | Primary long full coverage stenting |
|
| short spot | Active Comparator | primary short spot stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle-brachial index, etc |
|
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Inclusion Criteria:
Clinical criteria:
Age 20 years of older
Symptomatic peripheral artery disease:
Patients with signed informed consent
Anatomical criteria:
Exclusion Criteria:
Clinical criteria
Angiographic criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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|
| 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. |
|
| at 12 months according to the stenting strategy |
| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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