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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS-guided group | Experimental | Intravascular ultrasound-guided intervention group |
|
| Angiography-guided group | Active Comparator | Angiography-guided intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS-guided angioplasty | Procedure | Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedures lesion stenosis degree | Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival free from target vessel revascularization | Survival free from repeat intervention or surgical treatment due to loss of patency at the target vessel | 12 months |
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Inclusion Criteria:
Age 19 years or older
Symptomatic peripheral artery disease:
Femoropopliteal artery disease (stenosis > 50%)
ABI <0.9
Patients with signed informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39846915 | Derived | Lee SJ, Kim TH, Lee JH, Ahn CM, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Park HW, Jang JY, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB Investigators. Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease. JACC Cardiovasc Interv. 2025 Mar 10;18(5):558-569. doi: 10.1016/j.jcin.2024.10.052. Epub 2025 Jan 22. |
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|
| Angiography-guided angioplasty | Procedure | Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended. |
|