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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-INNOVA | Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| innova stent (Boston scientific) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate | Absence of restenosis >50% | 12 months after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion revascularization rate | 12 months | |
| Stent fracture rate | 12 months | |
| Quality of life |
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Inclusion Criteria:
Age 19 years of older
Symptomatic peripheral artery disease:
Femoropopliteal artery lesions with stenosis > 50%
ABI < 0.9
Patients with signed informed consent
Exclusion Criteria:
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Femoropopliteal artery disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Quality of life by standardized questionnaires
| 12 months |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |