AGIR Study: Angio-Seal in Interventional Radiology

Overview

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.

Full Title of Study: “Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

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.

Interventions

  • Procedure: Manual compression
    • Closure procedure by Manual compression
  • Device: Angio-Seal
    • Closure procedure by angio-Seal

Arms, Groups and Cohorts

  • Active Comparator: Angio-Seal
    • Closure procedure by Angio-Seal
  • Active Comparator: Manual compression
    • Closure procedure by manual compression

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of Patients With Mobilization Time Between 4-48 Hours
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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”.
  • Time to Discharge From Interventional Radiology Department
    • Time Frame: 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.
  • Percentage of Patients With Angio-Seal™ Deployment Success
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Alberto Mingo, PhD., Principal Investigator, Hospital Universitario de La Princesa, Madrid
    • Dr. Paolo Morgado, PhD., Principal Investigator, Hospital de São João, E.P.E.

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