Coronary AngiographyNCT03142126
Accelerated Ambulation After Vascular Access Closure Device
A study testing Early ambulation with Angioseal closure device in people with Coronary Angiography and Heart Catheterization, run by Henry Ford Health System.
Trial summary
The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Heart Catheterization
- What is being tested?
- Early ambulation with Angioseal closure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 6 Aug 2014to 5 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Inclusion Criteria: Patients undergoing diagnostic left heart catheterization.
Exclusion Criteria: Patients who do not meet criteria for Angioseal closure after diagnostic left heart catheterization.
About this study
Official title: Angioseal Groin Management After Left Heart Catheterization
The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort.
Read the detailed description
Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post procedure closure devices have been used in order to be able to ambulate patients after the procedure. Without closure device of the arterial sheath the typical time a patient must lay flat following a diagnostic left heart catheterization at Providence hospital is approximately six hours. This extended time of having to lie flat for the patient is both uncomfortable and time consuming for hospital employees.
The Angioseal closure device is a vascular plug that has been approved by the FDA in order to seal the femoral artery arteriotomy and allow for a faster ambulation time after cardiac catheterization. Currently, the Angioseal device has been approved for ambulation times of 20 minutes after diagnostic left heart catheterization but a more conservative approach is typically used after device. A very common strategy after Angioseal is to keep the patient flat for 2 hours prior to ambulation and then to keep the patient another hour after ambulation for observation of the femoral site.
While a conservative strategy may be considered safer to the operator the Angioseal device has already been approved for an early ambulation strategy. The goal of this study is to reaffirm the safety and efficacy of using Angioseal for early ambulation. If early ambulation is performed it could improve patient comfort and even reduce cost.
- Conditions
- Coronary Angiography, Heart Catheterization
- Being tested
- Early ambulation with Angioseal closure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ambulation with Angioseal closure deviceDevice
Also called Angioseal
To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy
| Study group | Role | What they receive |
|---|---|---|
| Early Ambulation | Experimental | To affirm the safety and efficacy of ambulation of 20 minutes after diagnostic left heart catheterization. Receives: Device: Early ambulation with Angioseal closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of device to achieve hemostasis
Continued bleeding after deployment prior to discharge
Measured: 20 minutes after procedure
Secondary outcomes (2)
Pseudoaneurysm
Clinical assessment in office follow-up visit
Measured: 7-10 days after discharge
Groin hematoma
Clinical assessment in office follow-up visit, 7-10 days after discharge
Measured: 7-10 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start6 Aug 2014
- Primary completion5 Aug 2015
- Study completion5 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible patients will receive early ambulation.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Hospital
- Responsible party
- Sponsor
- Investigators
- Marcel E Zughaib, MD, Study director, Program Director-Physician Residency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142126
- Sponsor's protocol ID
- 548976
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.
PubMed 22858390Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.
PubMed 21470671Brancheau D, Sarsam S, Assaad M, Zughaib M. Accelerated ambulation after vascular access closure device. Ther Adv Cardiovasc Dis. 2018 May;12(5):141-144. doi: 10.1177/1753944718756604. Epub 2018 Feb 8.
PubMed 29421959
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angioseal Groin Management After Left Heart Catheterization
- ClinicalTrials.gov ID
- NCT03142126
- Acronym / sponsor ID
- 548976
- Conditions
- Coronary Angiography, Heart Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Providence Hospital
- Study start
- 6 Aug 2014 (actual)
- Primary completion
- 5 Aug 2015 (actual)
- Study completion
- 5 Sep 2015 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort.
Detailed description
Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post procedure closure devices have been used in order to be able to ambulate patients after the procedure. Without closure device of the arterial sheath the typical time a patient must lay flat following a diagnostic left heart catheterization at Providence hospital is approximately six hours. This extended time of having to lie flat for the patient is both uncomfortable and time consuming for hospital employees.
The Angioseal closure device is a vascular plug that has been approved by the FDA in order to seal the femoral artery arteriotomy and allow for a faster ambulation time after cardiac catheterization. Currently, the Angioseal device has been approved for ambulation times of 20 minutes after diagnostic left heart catheterization but a more conservative approach is typically used after device. A very common strategy after Angioseal is to keep the patient flat for 2 hours prior to ambulation and then to keep the patient another hour after ambulation for observation of the femoral site.
While a conservative strategy may be considered safer to the operator the Angioseal device has already been approved for an early ambulation strategy. The goal of this study is to reaffirm the safety and efficacy of using Angioseal for early ambulation. If early ambulation is performed it could improve patient comfort and even reduce cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible patients will receive early ambulation.
| Arm | Type | Receives |
|---|---|---|
| Early Ambulation | Experimental | Device: Early ambulation with Angioseal closure deviceTo affirm the safety and efficacy of ambulation of 20 minutes after diagnostic left heart catheterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Early ambulation with Angioseal closure deviceAlso: AngiosealTo reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy | Device | Early Ambulation |
Primary outcome
Failure of device to achieve hemostasis
Time frame: 20 minutes after procedure
Continued bleeding after deployment prior to discharge
2 secondary outcomes
Pseudoaneurysm
Time frame: 7-10 days after discharge
Groin hematoma
Time frame: 7-10 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 22858390Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.
- Background: PubMed 21470671Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.
- Derived from this study: PubMed 29421959Brancheau D, Sarsam S, Assaad M, Zughaib M. Accelerated ambulation after vascular access closure device. Ther Adv Cardiovasc Dis. 2018 May;12(5):141-144. doi: 10.1177/1753944718756604. Epub 2018 Feb 8.
- Individual participant dataSharing planned: No
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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.
Marcel E Zughaib, MD study director
Program Director-Physician Residency
Questions about this trial
What is this clinical trial studying?
A study testing Early ambulation with Angioseal closure device in people with Coronary Angiography and Heart Catheterization, run by Henry Ford Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Failure of device to achieve hemostasis (time frame: 20 minutes after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142126, which also lists 3 linked publications.
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 Dec 2025.