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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atherectomy plus DCB | Active Comparator |
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| DCB | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination therapy of atherectomy and DCB | Procedure | The target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | Primary patency is defined as absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography | 12 months post treatment |
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Inclusion Criteria:
Age 19 years or older
Symptomatic peripheral artery disease:
Femoropopliteal artery disease (stenosis > 50%) with one of following complex lesion characteristics: - long lesion (>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
Patients with signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Guk Ko, MD, PhD | Contact | 82-2-2228-8460 | ygko@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
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| DCB alone | Procedure | The target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed. |
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