Vascular Access ComplicationAGIRNCT01911403
AGIR Study: Angio-Seal in Interventional Radiology
A study testing Manual compression and Angio-Seal in people with Vascular Access Complication, run by Abbott Medical Devices at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- Manual compression and Angio-Seal
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
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.
Read the 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.
- Conditions
- Vascular Access Complication
- Being tested
- Manual compression, Angio-Seal
- Keywords
- Femoral Artery puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual compressionProcedure or surgery
Closure procedure by Manual compression
Angio-SealDevice
Closure procedure by angio-Seal
| Study group | Role | What they receive |
|---|---|---|
| Angio-Seal | Active comparator | Closure procedure by Angio-Seal Receives: Device: Angio-Seal |
| Manual compression | Active comparator | Closure procedure by manual compression Receives: Procedure: Manual compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At discharge
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: At puncture closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startDec 2010
- Primary completionAug 2014
- Study completionSep 2014
Why it stopped: Low enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Alberto Mingo, PhD., Principal investigator, Hospital Universitario de La Princesa, MadridDr. Paolo Morgado, PhD., Principal investigator, Hospital de São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911403
- Sponsor's protocol ID
- CV08025POVC
- Acronym
- AGIR
- Status last verified
- Feb 2019
- First submitted
- 14 Apr 2011
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
- ClinicalTrials.gov ID
- NCT01911403
- Acronym / sponsor ID
- AGIR / CV08025POVC
- Conditions
- Vascular Access Complication
- Keywords
- Femoral Artery puncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rate.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 11 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angio-Seal | Active comparator | Device: Angio-SealClosure procedure by Angio-Seal |
| Manual compression | Active comparator | Procedure: Manual compressionClosure procedure by manual compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual compressionClosure procedure by Manual compression | Procedure or surgery | Manual compression |
| Angio-SealClosure procedure by angio-Seal | Device | Angio-Seal |
Primary outcome
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.
6 secondary outcomes
Number of Patients With Mobilization Time Between 4-48 Hours
Time frame: At discharge
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 Time to Hemostasis Between 0-4 Minutes
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 frame: At discharge
Percentage of Patients With Angio-Seal™ Deployment Success
Time frame: At puncture closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual compression and Angio-Seal in people with Vascular Access Complication, run by Abbott Medical Devices at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Mobilization Time Between 0-4 Hours (time frame: At discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.