AGIR Study: Angio-Seal in Interventional Radiology

Vascular Access Complication Clinical Trial

— AGIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01911403
• Other study ID #: CV08025POVC
• Status: Terminated
• Phase: N/A
• Start date: December 2010
• Est. completion date: September 2014

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Procedure:
• Manual compression
Closure procedure by Manual compression

Device:
• Angio-Seal
Closure procedure by angio-Seal

Locations

Country	Name	City	State
Portugal	Hospital de São João, E.P.E.	Porto
Spain	Hospital Universitario de La Princesa	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Mobilization Time Between 0-4 Hours	Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.	At discharge
Secondary	Number of Patients With Mobilization Time Between 4-48 Hours	Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.	At discharge
Secondary	Number of Patients With Any Complications	Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.; The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion.	At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)
Secondary	Number of Patients With Time to Hemostasis Between 0-4 Minutes	Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the "stop of bleeding".	At puncture closure
Secondary	Number of Patients With Time to Hemostasis Between 4-60 Minutes	Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the "stop of bleeding".	At puncture closure
Secondary	Time to Discharge From Interventional Radiology Department	Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.	At discharge
Secondary	Percentage of Patients With Angio-Seal™ Deployment Success	According the physician criteria, it will be "YES" If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture.	At puncture closure