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DCB can maximize the patency rate of blood vessels on the basis of intraluminal DA. DA+DCB treatment is effective and safe [8], and the advantages of DA and DCB in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. The combined application of DA and DCB in the treatment of peripheral arterial disease has a good early and mid-term effect. Konstantinos et al. reported that DARRT has a higher first-phase patency rate compared with DCB. A retrospective study by Sebastian et al. showed that compared with PTA after DA, the combination of DA and DCB has a better event-free survival rate after 12 months of follow-up. Therefore, DA combined with DCB therapy may be one of the best and most promising methods for the treatment of lower extremity ASO.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TurboHawk | Device | Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel | ||
| Paclitaxel | Drug | Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Primary vascular patency rate | Free-Target lesion reconstruction rate(F-TLR)at 24 months after operation | 24 months |
| Major adverse event | MAE within 24 months after surgery | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | Quality of life assessment (VAS-QOL) after discharge, 1, 3, 6, 12, and 24 months after operation | 24 months |
| ABI | Ankle-brachial index (ABI) at discharge, 1, 3, 6, 12, and 24 months after operation |
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Inclusion Criteria:
Exclusion Criteria:
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ASO patients with femoral popliteal artery occlusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| 24 months |
| Rutherford classification | Discharge, 1, 3, 6, 12, and 24 months after the Rutherford classification | 24 months |
| TLR | The incidence of TLR after discharge, 1, 3, 6, 12, and 24 months | 24 months |
| TVR | The incidence of TVR after discharge, 1, 3, 6, 12, and 24 months | 24 months |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |