AGIR Study: Angio-Seal in Interventional Radiology

Abbott

Status

Terminated

Conditions

Vascular Access Complication

Treatments

Device: Angio-Seal

Procedure: Manual compression

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911403

CV08025POVC

Details and patient eligibility

About

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.

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

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

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.