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This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZENFLEX ® Pinto | Experimental | subjects using the spot stent(ZENFLEX ® Pinto) system |
|
| Everflex | Active Comparator | subjects using the bare stent(Everflex) system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the spot stent(ZENFLEX ® Pinto) system | Device | the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA) |
| Measure | Description | Time Frame |
|---|---|---|
| primary patency rate at 12 months after operation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of the device | Intraoperation | |
| success rate of the technique | post operation | |
| rate of CD-TLR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jie Liang | Contact | 13819565660 | jie.liang@zyloxmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoqiang Li | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China |
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| the bare stent( Everflex) system | Device | the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA) |
|
| 6 months,12 months |
| ABI | post operation, 6 months,12 months |
| Rutherford classification | post operation, 6 months,12 months |
| the incidence of major adverse events | 30 days, 6 months,12 months |
| the rate of target limb major amputation | 30 days, 6 months,12 months |
| the incidence of adverse events | Intraoperation, post operation, 30 days, 6 months,12 months |
| the incidence of SAE | Intraoperation, post operation, 30 days, 6 months,12 months |
| the rate of device defect | Intraoperation, 12 months |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | China |
|
| Changzhou First People's Hospital | Changzhou | China |
|
| Changzhou Second People's Hospital | Changzhou | China |
|
| The First Affiliated Hospital of Harbin Medical University | Ha’erbin | China |
|
| Anhui Provincial Hospital | Hefei | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China |
|
| Nanjing Drum Tower Hospital | Nanjing | China |
|
| Affiliated Hospital of Qingdao University | Qingdao | China |
|
| Shanghai Ninth People's Hospital | Shanghai | China |
|
| Tianjin Medical University General Hospital | Tianjin | China |
|
| North Jiangsu People's Hospital | Yangzhou | China |
|
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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