AGIR Study: Angio-Seal in Interventional Radiology

Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology

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.

It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.

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 months, with a follow-up period of 2 weeks (± 1 week).

The randomization will be stratified according to the type of procedure.

Inclusion Criteria:

• 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 Criteria:

• 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.