Peripheral Vascular DiseaseNCT00817349
Angio-Seal Evolution Device Registry
An observational study of Peripheral Vascular Disease and Coronary Artery Disease, run by Abbott Medical Devices at 10 sites in United States.
Trial summary
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease
- How many people
- 1,004 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2008to Apr 2010
- Phase
- Observational
- 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
Study population: Those needing a diagnostic and/or interventional catheterization procedure.
Who may be able to join
- Patient is having a diagnostic and/or interventional procedure via femoral artery access.
Who cannot join
- Patients who are unable to provide written informed consent.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Main Line Health Heart Center: Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Cooper Health System
Camden, New Jersey, 08103
Ohiohealth Research Institute @ Riverside Methodist Hospital
Columbus, Ohio, 43214
Altru Health System Hospital
Grand Forks, North Dakota, 58201
Baptist Hospital West
Knoxville, Tennessee, 37934
Good Samaritan Hospital
Los Angeles, California, 90017
Providence Health & Services
Portland, Oregon, 97225
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
Main Line Health Heart Center: Lankenau Hospitals
Wynnewood, Pennsylvania, 19096
Michigan Heart, P.C.
Ypsilanti, Michigan, 48197
About this study
Official title: Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
Read the detailed description
This multi-center clinical registry is designed to collect data on the use of the Angio-Seal Evolution Device in patients who have had diagnostic and/or interventional procedures through femoral artery access. Data will be collected on a patient's initial screening through hospital discharge and 30 days post-procedure to evaluate major and minor vascular complications as defined in the protocol.
- Conditions
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease, Coronary Heart Disease
- Keywords
- Angio-Seal, Peripheral vascular disease, Vascular closure device, Arterial closure, Coronary artery disease, Arterial hemostasis, Coronary cardiac catheterization, Percutaneous coronary intervention, Interventional catheterization, Diagnostic catheterization, Common femoral artery, Manual compression, Vascular intervention, Angiogram, Coronary intervention, Coronary angioplasty, Angiography, Arteriotomy, Vascular access
- Medical subject headings
- Peripheral Vascular Diseases, Coronary Artery Disease, Peripheral Arterial Disease, Arterial Occlusive Diseases, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect major vascular complications
Measured: 30 days post-procedure
Secondary outcomes (2)
Assess time artery stops bleeding
Measured: Immediately following procedure
Collect minor vascular complications
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Applegate, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817349
- Sponsor's protocol ID
- 0801
- Status last verified
- Feb 2019
- First submitted
- 5 Jan 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.
PubMed 20814049
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registry of the St. Jude Medical Angio-Seal(TM) Evolution(TM) Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
- ClinicalTrials.gov ID
- NCT00817349
- Acronym / sponsor ID
- 0801
- Conditions
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease, Coronary Heart Disease
- Keywords
- Angio-Seal, Peripheral vascular disease, Vascular closure device, Arterial closure, Coronary artery disease, Arterial hemostasis, Coronary cardiac catheterization, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 Jan 2009 (estimated)
- 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.
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
Detailed description
This multi-center clinical registry is designed to collect data on the use of the Angio-Seal Evolution Device in patients who have had diagnostic and/or interventional procedures through femoral artery access. Data will be collected on a patient's initial screening through hospital discharge and 30 days post-procedure to evaluate major and minor vascular complications as defined in the protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those needing a diagnostic and/or interventional catheterization procedure.
Key inclusion criteria (1 listed)
- Patient is having a diagnostic and/or interventional procedure via femoral artery access.
Key exclusion criteria (1 listed)
- Patients who are unable to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect major vascular complications
Time frame: 30 days post-procedure
2 secondary outcomes
Assess time artery stops bleeding
Time frame: Immediately following procedure
Collect minor vascular complications
Time frame: 30 days post-procedure
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 4 Feb 2019.
- Derived from this study: PubMed 20814049Applegate RJ, Turi Z, Sachdev N, Ahmed A, Szyniszewski A, Foster M, Pratsos A, Shapiro T, Yakubov S, Shavelle D. The Angio-Seal Evolution registry: outcomes of a novel automated Angio-Seal vascular closure device. J Invasive Cardiol. 2010 Sep;22(9):420-6.
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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.
Robert Applegate, MD principal investigator
Wake Forest University Health Sciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Coronary Artery Disease, run by Abbott Medical Devices at 10 sites in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 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 10 sites in United States. 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?
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?
Collect major vascular complications (time frame: 30 days post-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 NCT00817349, which also lists 1 linked publication.
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 4 Feb 2019.