AGIR Study: Angio-Seal in Interventional Radiology

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vascular Access Complication

Intervention / Treatment
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* Procedure: Manual compression
* Device: Angio-Seal


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angio-Seal<br>Closure procedure by Angio-Seal | Device: Angio-Seal<br>* Closure procedure by angio-Seal<br>|
| Active Comparator: Manual compression<br>Closure procedure by manual compression | Procedure: Manual compression<br>* Closure procedure by Manual compression<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral Artery puncture