AGIR Study: Angio-Seal in Interventional Radiology (AGIR)

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.

Study Overview

• Status: Terminated
• Conditions: Vascular Access Complication
• Intervention / Treatment: Device: Angio-Seal; Procedure: Manual compression

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

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

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4202-451
    • Hospital de Sao Joao, E.P.E.
• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Angio-Seal; Closure procedure by Angio-Seal	Device: Angio-Seal; Closure procedure by angio-Seal
ACTIVE_COMPARATOR: Manual compression; Closure procedure by manual compression	Procedure: Manual compression; Closure procedure by Manual compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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
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
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Dr. Alberto Mingo, PhD., Hospital Universitario de la Princesa, Madrid; Principal Investigator: Dr. Paolo Morgado, PhD., Hospital de Sao Joao, E.P.E.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (ESTIMATE): July 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Femoral Artery puncture
• Other Study ID Numbers: CV08025POVC