Aortic Aneurysm, ThoracicNCT00590759

Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms

A study testing GORE TAG® Thoracic Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 25 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Aortic Aneurysm, Thoracic
What is being tested?: GORE TAG® Thoracic Endoprosthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 25 sitesUnited States
Study dates: Aug 2005to Apr 2013
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Descending thoracic aortic aneurysm deemed to warrant surgical repair:
Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
Saccular aneurysm
Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
<60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment

Show all 14Show fewer

Life expectancy > 2 years
Surgical Candidate
ASA Class I, II, III, or IV
NYHA Class I, II, III or no heart disease
Male or infertile female
Minimum 21 years of age
Able to comply with protocol requirements
Signed Informed Consent Form

Who cannot join

4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
Significant thrombus at the proximal or distal implantation zones
Mycotic aneurysm
Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
Acute or chronic aortic dissection
Planned occlusion of the left carotid or celiac arteries

Show all 13Show fewer

"Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days
Myocardial infarction or cerebral vascular accident within 6 weeks
Severe respiratory insufficiency sufficient that precludes open thoracotomy
Renal insufficiency (Creatinine > 2.0 mg/dL) with or without dialysis
Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
Participation in another investigational device or drug study within 1 year
Documented history of drug abuse within 6 months

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Study site
Albany, New York
Study site
Boston, Massachusetts
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Gainesville, Florida
Study site
Greeley, Colorado
Study site
Kansas City, Kansas
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Peoria, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Temple, Texas
Study site
Vancouver, Washington

Other trials in United States

About this study

Official title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms

Conditions: Aortic Aneurysm, Thoracic
Being tested: GORE TAG® Thoracic Endoprosthesis
Medical subject headings: Aortic Aneurysm, Thoracic

What participants receive

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

GORE TAG® Thoracic EndoprosthesisDevice
implant

Study groups in NCT00590759
Study group	Role	What they receive
GORE TAG® Thoracic Endoprosthesis	Other	Not described Receives: Device: GORE TAG® Thoracic Endoprosthesis

What is being measured

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

Aneurysm Related Death
Freedom from aneurysm related mortality for TAG 05-02 subjects
Measured: 5 years

Secondary outcomes (1)

A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
Proportion of subjects in TAG 05-02 with MAEs
Measured: 5 years

Timeline

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

Aug 2005Apr 2013

First posted11 Jan 2008 (estimated)
Study startAug 2005
Primary completionApr 2013
Study completionApr 2013

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 Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00590759
Sponsor's protocol ID: TAG 05-02
Status last verified: Aug 2014
First submitted: 20 Dec 2007
Last updated: 7 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair
Recruiting
MBA Early Feasibility Study
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)

All Aortic Aneurysm, Thoracic trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
ClinicalTrials.gov ID: NCT00590759
Acronym / sponsor ID: TAG 05-02
Conditions: Aortic Aneurysm, Thoracic
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 11 Jan 2008 (estimated)
Results: Posted 7 Aug 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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GORE TAG® Thoracic Endoprosthesis	Other	Device: GORE TAG® Thoracic Endoprosthesis

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Descending thoracic aortic aneurysm deemed to warrant surgical repair:
Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
Life expectancy > 2 years
Surgical Candidate

Key exclusion criteria (13 listed)

4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
Significant thrombus at the proximal or distal implantation zones
Mycotic aneurysm
Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
Acute or chronic aortic dissection

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
GORE TAG® Thoracic Endoprosthesisimplant	Device	GORE TAG® Thoracic Endoprosthesis

Primary outcome

Aneurysm Related Death
Time frame: 5 years
Freedom from aneurysm related mortality for TAG 05-02 subjects

1 secondary outcome

A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
Time frame: 5 years

Results and safety

Results posted to the registry on 7 Aug 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
Thoracic Endograft	150	70

Primary outcome: Aneurysm Related Death

Time frame: 5 years. Number. Unit: participants

Measure	Thoracic Endograft n = 150
Value	4

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Total Study Follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0502 TAG Device Subjects	0 of 150 (0%)	147 of 150 (98%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Aortic Aneurysm, Thoracic

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair
Recruiting
MBA Early Feasibility Study
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)

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.

Mark Morasch, M.D. principal investigator

St. Vincent's Healthcare, Billings MT

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GORE TAG® Thoracic Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 25 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 14 inclusion and 13 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 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 7 Aug 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?

Aneurysm Related Death (time frame: 5 years). 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 NCT00590759.

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 7 Aug 2014.