AGIR Study: Angio-Seal in Interventional Radiology

N/ATerminatedNCT01911403

Abbott Medical Devices123 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Vascular Access Complication

Interventions

Manual compressionPROCEDURE

Closure procedure by Manual compression

Angio-SealDEVICE

Closure procedure by angio-Seal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hospital de São João, E.P.E.

Porto, Portugal

Hospital Universitario de La Princesa

Madrid, Spain

Outcomes

Primary Outcomes

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.

Time frame: At discharge

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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".

Time frame: At puncture closure

Number of Patients With Time to Hemostasis Between 4-60 Minutes

Time frame: 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.

Data from ClinicalTrials.gov

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