N/A
N=634
Angio-Seal Interventional Radiology (IR) Registry
Diagnostic and/or Interventional Radiology Procedures
Bottom Line
View on ClinicalTrials.gov: NCT01222104 ↗Enrolled (actual)
634
Serious AEs
2.4%
Results posted
Nov 2014
Primary outcome: Primary: Rate of Major Vascular Complications — 0.7 Percentage of Procedures
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Major Vascular Complications |
0.7 | — |
| SECONDARY Time to Hemostasis |
84.9; 13.0; 2.1 | — |
| SECONDARY Rate of Minor Vascular Complications |
0.7 | — |
| SECONDARY Impact of Guided Access on Use of Closure Device. |
90.0; 86.7; 88.2; 73.1 | — |
| SECONDARY Impact of Guided Access on Achieving Target Puncture Location. |
87.0; 81.7; 77.0; 87.0 | — |
| SECONDARY Rate of Major Vascular Complications (MVCs) by Guided Access Mode. |
0; 1.1; 0.8; 0 | — |
| SECONDARY Rate of Minor Vascular Complications by Guided Access Mode. |
0; 0.7; 1.6; 0 | — |
| SECONDARY Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device |
93.1; 78.0 | — |
| SECONDARY Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device |
98.7; 97.7 | — |
| SECONDARY Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) |
0.4; 1 | — |
| SECONDARY Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) |
1.3; 0.3 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01222104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.