Clinical trial NCT01911403: AGIR Study: Angio-Seal in Interventional Radiology
Official title: Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Access Complication
Keywords: Femoral Artery puncture
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Mobilization Time Between 0-4 Hours
timeFrame: At discharge
Secondary outcomes:
measure: Number of Patients With Mobilization Time Between 4-48 Hours
timeFrame: At discharge
measure: Number of Patients With Any Complications
timeFrame: At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)
measure: Number of Patients With Time to Hemostasis Between 0-4 Minutes
timeFrame: At puncture closure
measure: Number of Patients With Time to Hemostasis Between 4-60 Minutes
timeFrame: At puncture closure
measure: Time to Discharge From Interventional Radiology Department
timeFrame: At discharge
measure: Percentage of Patients With Angio-Seal™ Deployment Success
timeFrame: At puncture closure
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Hospital de São João, E.P.E.
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: Hospital Universitario de La Princesa, Madrid
name: Dr. Alberto Mingo, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de São João, E.P.E.
name: Dr. Paolo Morgado, PhD.
role: PRINCIPAL_INVESTIGATOR
References: