NCT Number: NCT01222104
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.
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Sex eligibility
All sexes
Study type
Observational
Primary location
Loma Linda University Medical Center, Loma Linda, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
- Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.
Exclusion criteria
- Patients who are unable to provide written informed consent.
Treatment and study plan
Primary outcomes
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Rate of Major Vascular Complications
Time frame: 30 days
Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.
The following are defined as a major vascular complication:
- Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;
- Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;
- Access site related bleeding requiring transfusion;
- New ipsilateral lower extremity ischemia requiring surgical intervention;
- Retroperitoneal bleeding;
- Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;
- Access related complication that results in extended hospital stay;
- Death
Secondary outcomes
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Time to Hemostasis
Time frame: Procedure
Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.
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Rate of Minor Vascular Complications
Time frame: 30 days
The following are defined as a minor vascular complication:
- Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;
- Ipsilateral hematoma >10 cm;
- Ipsilateral pseudoaneurysm without intervention;
- Ipsilateral arteriovenous fistula;
- Ipsilateral deep vein thrombosis;
- Local access site infection without prolonged hospitalization
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Impact of Guided Access on Use of Closure Device.
Time frame: 30 days
The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.
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Impact of Guided Access on Achieving Target Puncture Location.
Time frame: 30 days
The influence of fluoroscopy and/or ultrasound guided access on puncture location.
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Rate of Major Vascular Complications (MVCs) by Guided Access Mode.
Time frame: 30 days
The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).
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Rate of Minor Vascular Complications by Guided Access Mode.
Time frame: 30 days
The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.
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Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device
Time frame: 30 days
Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device
-
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device
Time frame: 30 days
Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.
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Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)
Time frame: 30 days
Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).
-
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)
Time frame: 30 days
Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.
Sponsors and collaborators
Lead sponsor
Abbott Medical Devices
Industry
Registry information
Official study title
Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Oct 18, 2010
- Registry last updated
- Feb 5, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.