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The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB catheter | Experimental | Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB catheter | Device | Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014") |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency | Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse event (MAE) rate | Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR | 30 days |
| Patency rate | Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuang Baixi | Contact | 010-62835122 | zhuangbaixi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhuang Baixi | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chui Yang Liu Hospital affiliated to Tsinghua University | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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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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| 12 months,24 months,36 months,48 months ,60 months |
| Rate of major target limb amputation | A major adverse limb event is defined as above-ankle amputation of the treated limb | 12 months,24 months,36 months,48 months ,60 months |
| Rate of All-cause mortality | All-cause mortality at 12, 24, 36, 48, 60 months post procedure | 12 months,24 months,36 months,48 months ,60 months |
| Rate of clinically-driven target vessel revascularization (CD-TVR) | Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure | 12 months,24 months,36 months,48 months ,60 months |
| Rate of clinically-driven target lesion revascularization (CD-TLR) | Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure | 12 months,24 months,36 months,48 months ,60 months |
| Rate of ulcer healing | Ulcer healed or not; if not, improving, stagnant,worsening | 12 months,24 months,36 months,48 months ,60 months |
| Rate of distal embolization | Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure | through procedure completion |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |