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"• A prospective, single-center randomized controlled comparison trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiography-guided angioplasty | Active Comparator | In this group, balloon angioplasty will be performed on the target infrapopliteal artery lesion to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis >50% or any flow-limiting dissection. |
|
| Pressure wire-guided angioplasty | Experimental | In this gorup, balloon angioplasty will be performed on the target infrapopliteal artery lesions to achieve an optimal procedural result, as determined by the pressure gradient across the target lesion. An optimal procedural result is defined as pressure gradient less than 10 mmHg, measured using a Pressure Wire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiography-guided angioplasty | Procedure | Balloon angioplasty will be performed on the target infrapopliteal artery lesion to achieve an optimal procedural result, as determined by angiography. Optimal results are defined as antegrade blood flow without residual stenosis >50% or any flow-limiting dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| Attainment rate of postprocedural skin perfusion pressure ≥50 mmHg | within 3 days after the index endovascular therapy | Attainment rate of postprocedural skin perfusion pressure≥50 mmHg within 3 days after the indez endovascular therapy |
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Inclusion Criteria:
Exclusion Criteria:
Acute limb ischemia
Contraindication to antiplatelet or anticoagulation agents:
Pregnant women or women with potential childbearing
Life expectancy < 1 year
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Guk Ko, MD. Division of Cardiology | Contact | +82-2-228-8451 | ygko@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular hospital Department of Internal Medicine, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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|
| Pressure wire-guided angioplasty | Procedure | Balloon angioplasty will be performed on the target infrapopliteal artery lesions to achieve an optimal procedural result, as determined by the pressure gradient across the target lesion. An optimal procedural result is defined as pressure gradient less than 10 mmHg, measured using a Pressure Wire. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |