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This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).
Prospective, single-center, randomized (1:1), open-label, non-inferiority study in 1062 patients comparing Perclose ProGlide (test device) to the Angio-seal VIP (standard comparator).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perclose ProGlide | Active Comparator | Perclose ProGlide 6F Suture-Mediated Closure (SMC) System |
|
| Angio-seal VIP | Placebo Comparator | Angio-seal VIP Vascular Closure Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perclose ProGlide | Device | After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days | Deployment procedure success is defined as haemostasis after the delivery and release of a closure device, manual compression is no longer needed or less than 5 minutes, and no more closure devices are needed. Major vascular complications include:
| 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required | Minor ipsilateral access site vascular complications included:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiongjing Jiang, MD | Contact | +861088322385 | jxj103@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiongjing Jiang, MD | Fuwai Hospital, National Center for Cardiovascular Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Angio-seal VIP | Device | After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP |
|
| 30 days post procedure |
| Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) | Major vascular complications include:
| 180 days post procedure |
| Deployment procedure time | Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time) | within 24 hours of device deployment |
| Time to haemostasis from removing the sheath until haemostasis | Haemostasis is considered as insignificant bleeding on the bandage or small continuous oozing, manual compression is no longer needed or less than 5 minutes. | within 24 hours of device deployment |
| Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS) | 0 cm means no pain, while 10 cm means the worst imaginable pain or the worst pain one had experienced | within 5 minutes of device deployment |
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