AGIR Study: Angio-Seal in Interventional Radiology

Not Applicable

Terminated

Conditions: Vascular Access Complication

Interventions: Procedure: Manual compression
Device: Angio-Seal

Registration Number: NCT01911403

Lead Sponsor: Abbott Medical Devices

Brief 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 123

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual compression	Manual compression	Closure procedure by manual compression
Angio-Seal	Angio-Seal	Closure procedure by Angio-Seal

Primary Outcome Measures

Name	Time	Method
Number of Patients With Mobilization Time Between 0-4 Hours	At discharge	Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.

Secondary Outcome Measures

Name	Time	Method
Time to Discharge From Interventional Radiology Department	At discharge	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.
Number of Patients With Mobilization Time Between 4-48 Hours	At discharge	Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.
Number of Patients With Any Complications	At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)	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.
Number of Patients With Time to Hemostasis Between 0-4 Minutes	At puncture closure	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".
Number of Patients With Time to Hemostasis Between 4-60 Minutes	At puncture closure	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".
Percentage of Patients With Angio-Seal™ Deployment Success	At puncture closure	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.