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| Name | Class |
|---|---|
| CCRF Inc., Beijing, China | INDUSTRY |
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This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Tri-wire Peripheral Balloon Dilatation Catheter | Experimental | Percutaneous transluminal angiography (PTA) will be performed using the Tri-wire Peripheral Balloon Dilatation Catheter. Interventions: Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter; Procedure: Percutaneous Transluminal Angiography. |
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| Active Comparator: OHICHO Ⅱ PTA Balloon Catheter. | Active Comparator | Percutaneous transluminal angiography (PTA) will be performed using OHICHO Ⅱ PTA Balloon Catheter, a commercially available high-pressure PTA balloon. Multiple balloons, inflations and/or prolonged inflation may be used. Interventions: Device: OHICHO Ⅱ PTA Balloon Catheter. Procedure: Percutaneous Transluminal Angiography. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter | Combination Product | Procedure: Percutaneous Transluminal Angiography, Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | The target lesion residual stenosis<30% | Right after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | During the operation, Balloon dilatation catheters can be delivered to the target lesion, inflated≤RBP without rupture and withdrawed successfully | Right after operation |
| Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qizhuang Jin | Contact | 13301011122 | jinqizhuang@bjmu.edu.cn | |
| Yanqi Yin | Contact | 13810454638 | thomasyq135@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qizhuang Jin | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Base on the technical success, without MAE including death, thrombosis, allergic reactions, pulmonary diseases (pulmonary edema)
| 12-48 hours |
| Dilating Pressure | The minimum pressure with which the balloon can be completely inflated without waist during the operation | During the operation |
| Pain Score | The pain during dilating procedure, measured by NRS (increase from 0 to 10) | Right after operation |
| Target Lesion Primary Patency (TLPP) | Defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. TLPP ends with a clinically driven re-intervention of the target lesion or access thrombosis. | 1 month |
| Target lesion restenosis | Target lesion diameter restenosis rate(measured by DUS)=100%*(1-(MLD/RVD)) (MLD includes 5mm range of proximal and distal of targer lesions | 1 month |
| Fistula Blood Flow | Measured Brachial artery blood flow of arteriovenous fistula flow assessed by DUS. | 1 month |
| Adverse Events | Number of device and procedure related adverse events (CEC Adjudicated) | 1 month |
| Beijing Tongren Hospital | Beijing | Beijing Municipality | 100730 | China |
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| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 510630 | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
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| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
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| Longhua Hospital Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200032 | China |
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| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhengjiang | 310016 | China |
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| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |