TerminatedNot Applicable

AGIR Study: Angio-Seal in Interventional Radiology

Stopped: Low enrollment rate.

Portugal, Spain123 participantsStarted 2010-12

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Patients With Mobilization Time Between 0-4 Hours

Timeframe: At discharge

Trial details

NCT IDNCT01911403

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2015-02-26

View on ClinicalTrials.gov More Vascular Access Complication trials