Diagnostic and/or Interventional Radiology ProceduresNCT01222104

Angio-Seal Interventional Radiology (IR) Registry

An observational study of Diagnostic and/or Interventional Radiology Procedures, run by Abbott Medical Devices at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diagnostic and/or Interventional Radiology Procedures
How many people: 634 participants
Where: 10 sitesUnited States
Study dates: Oct 2010to May 2011
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients who undergo a diagnostic and/or interventional radiology procedure through percutaneous femoral artery access and meet the registry selection criteria.

Who may be able to join

Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.

Who cannot join

1. Patients who are unable to provide written informed consent.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Kaleida Health
Buffalo, New York, 14209
Mayfield Clinic, Inc.; The University Hospital
Cincinnati, Ohio, 45219
Riverside Methodist Hospital
Columbus, Ohio, 43214
University of Florida
Gainesville, Florida, 32610
University of Kansas Medical Center
Kansas City, Kansas, 66160
Loma Linda University Medical Center
Loma Linda, California, 92354
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Yale New Haven Hospital
New Haven, Connecticut, 06520
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141

Other trials in United States

About this study

Official title: Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures

Conditions: Diagnostic and/or Interventional Radiology Procedures
Keywords: vascular closure, Angio-Seal, Interventional radiology, femoral artery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01222104
Study group	Role	What they receive
Angio-Seal		Angio-Seal attempted and/or deployed
Not deployed		Other method of closure

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Major Vascular Complications
Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.
The following are defined as a major vascular complication:
1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;
2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;
3. Access site related bleeding requiring transfusion;
4. New ipsilateral lower extremity ischemia requiring surgical intervention;
5. Retroperitoneal bleeding;
6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;
7. Access related complication that results in extended hospital stay;
8. Death
Measured: 30 days

Secondary outcomes (10)

Time to Hemostasis
Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.
Measured: Procedure
Rate of Minor Vascular Complications
The following are defined as a minor vascular complication:
1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;
2. Ipsilateral hematoma >10 cm;
3. Ipsilateral pseudoaneurysm without intervention;
4. Ipsilateral arteriovenous fistula;
5. Ipsilateral deep vein thrombosis;
6. Local access site infection without prolonged hospitalization
Measured: 30 days
Impact of Guided Access on Use of Closure Device.
The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.
Measured: 30 days
Impact of Guided Access on Achieving Target Puncture Location.
The influence of fluoroscopy and/or ultrasound guided access on puncture location.
Measured: 30 days
Rate of Major Vascular Complications (MVCs) by Guided Access Mode.
The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).
Measured: 30 days
Rate of Minor Vascular Complications by Guided Access Mode.
The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.
Measured: 30 days
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device
Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device
Measured: 30 days
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device
Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.
Measured: 30 days
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)
Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).
Measured: 30 days
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)
Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010May 2011

First posted18 Oct 2010 (estimated)
Study startOct 2010
Primary completionMay 2011
Study completionMay 2011

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 Diagnostic and/or Interventional Radiology ProceduresStudies 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: Cohort
Time perspective: Prospective
Enrolment: 634 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01222104
Sponsor's protocol ID: 0903
Status last verified: Feb 2019
First submitted: 5 Oct 2010
Last updated: 5 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 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Registry of St. Jude Medical Angio-Seal™ Vascular Closure Devices Following Interventional Radiology Procedures
ClinicalTrials.gov ID: NCT01222104
Acronym / sponsor ID: 0903
Conditions: Diagnostic and/or Interventional Radiology Procedures
Keywords: vascular closure, Angio-Seal, Interventional radiology, femoral artery
Study type: Observational
Recruitment status: Completed
Enrolment: 634 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 18 Oct 2010 (estimated)
Results: Posted 19 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Angio-Seal	–	–Angio-Seal attempted and/or deployed
Not deployed	–	–Other method of closure

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who undergo a diagnostic and/or interventional radiology procedure through percutaneous femoral artery access and meet the registry selection criteria.

Key inclusion criteria (2 listed)

Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.

Key exclusion criteria (1 listed)

1. 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

Rate of Major Vascular Complications
Time frame: 30 days
Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure. The following are defined as a major vascular complication: 1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means; 2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention; 3. Access site related bleeding requiring transfusion; 4. New ipsilateral lower extremity ischemia requiring surgical intervention; 5. Retroperitoneal bleeding; 6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics; 7. Access related complication that results in extended hospital stay; 8. Death

10 secondary outcomes

Time to Hemostasis
Time frame: Procedure
Rate of Minor Vascular Complications
Time frame: 30 days
Impact of Guided Access on Use of Closure Device.
Time frame: 30 days
Impact of Guided Access on Achieving Target Puncture Location.
Time frame: 30 days
Rate of Major Vascular Complications (MVCs) by Guided Access Mode.
Time frame: 30 days
Rate of Minor Vascular Complications by Guided Access Mode.
Time frame: 30 days
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device
Time frame: 30 days
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device
Time frame: 30 days
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)
Time frame: 30 days
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)
Time frame: 30 days

Results and safety

Results posted to the registry on 19 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	634	587

Primary outcome: Rate of Major Vascular Complications

Time frame: 30 days. Number. Unit: Percentage of Procedures

Measure	Angio -Seal n = 534
Value	0.7

Population analysed: 5 subjects underwent vascular closure with Angio-Seal on right and left sides.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	15 of 634 (2.4%)	4 of 634 (0.6%)	Not reported

Limitations and caveats (from the sponsor): Major and minor vascular complications were collected as Serious Adverse Event and Other Adverse Events as defined in the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Zoltan Turi, M.D. principal investigator

Cooper University

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 Diagnostic and/or Interventional Radiology Procedures, 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 2 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 5 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?

Yes. Results are posted in the registry (first posted 19 Nov 2014). 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?

Rate of Major Vascular Complications (time frame: 30 days). 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 NCT01222104.

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 5 Feb 2019.