Status:
TERMINATED
AGIR Study: Angio-Seal in Interventional Radiology
Lead Sponsor:
Abbott Medical Devices
Conditions:
Vascular Access Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access...
Detailed Description
Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression. Patients will be enrolled in the study during 12 month...
Eligibility Criteria
Inclusion
- Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)
- Patient available for follow-up at 2 weeks
- Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.
Exclusion
- Access unsuitable for use of Angio-Sea
- Presence of calcification at the puncture site
- Presence of visible hematoma at the end of the procedure
- Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
- Patients who are pregnant.
- Patients currently participating in a clinical investigation that includes an active treatment arm.
- Contraindication for ambulation at 2 hours after the end of the procedure
- Patients with a life expectancy of less then 1 month.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01911403
Start Date
December 1 2010
End Date
September 1 2014
Last Update
February 19 2019
Active Locations (2)
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1
Hospital de São João, E.P.E.
Porto, Portugal, 4202-451
2
Hospital Universitario de La Princesa
Madrid, Spain, 28006