Thoracic Aortic AneurysmSTARZ-TX2NCT00111176
STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
A study testing Endovascular repair and Surgical in people with Thoracic Aortic Aneurysm, run by Cook Group Incorporated at 41 sites in 3 countries.
Trial summary
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm
- What is being tested?
- Endovascular repair and Surgical
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 41 sitesin 3 countries
- Study dates
- Mar 2004to May 2013
- 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
Who may be able to join
- Patients diagnosed with aneurysms / ulcers of the descending thoracic aorta
- Patients who are candidates for either surgery or endovascular repair
- Patients at least 18 years old
Who cannot join
- Age < 18 years
- Patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years)
- Patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months
- Patients unwilling or unable to comply with the follow-up schedule
- Patients unable or who refuse to give informed consent
- Patients simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
United States38 sites
Albany Medical Center
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Union Memorial Hospital
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Duke University Medical Center
Durham, North Carolina, 27710
Swedish Medical Center
Englewood, Colorado, 80113
MeritCare
Fargo, North Dakota, 58122
University of Florida
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
Memorial Hermann Hospital
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46260
Mayo Clinic
Jacksonville, Florida, 32224
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Banner Desert Medical Center
Mesa, Arizona, 85202
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
New York University Hospital
New York, New York, 10016
Lenox Hill Hospital
New York, New York, 10021
New York Presbyterian - Cornell
New York, New York, 10021
New York Presbyterian Hospital - Columbia
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Arizona Heart Institute
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Rochester
Rochester, New York, 14642
University of California, San Francisco
San Francisco, California, 94143
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Stanford University Hospital and Clinics
Stanford, California, 94305
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada2 sites
Peter Lougheed Center
Calgary, Alberta, T1Y-6J4
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, V6T 2B5
About this study
Official title: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.
Read the detailed description
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2(R) TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers. Instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture.
The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.
- Conditions
- Thoracic Aortic Aneurysm
- Being tested
- Endovascular repair, Surgical
- Keywords
- Thoracic Aortic Aneurysm, Descending, minimally invasive, endovascular, rupture, back pain, stent graft, endovascular aneurysm repair, aortic aneurysm, thoracic
- Medical subject headings
- Aortic Aneurysm, Thoracic, Rupture, Back Pain, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular repairDevice
Also called TEVAR
Endovascular repair.
SurgicalProcedure or surgery
Surgical endovascular repair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Endovascular Repair Receives: Device: Endovascular repair |
| 2 | Other | Surgical Receives: Procedure: Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary hypothesis for effectiveness is that patients treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent 30-day rupture-free survival compared to the surgical control.
Measured: 30 days
Secondary outcomes (1)
A secondary hypothesis is subjects treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent or fewer complications compared to the surgical control group through 30 days following implant.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2005 (estimated)
- Study startMar 2004
- Primary completionJul 2007
- Study completionMay 2013
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 Thoracic Aortic AneurysmStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- William Cook Europe, William Cook Australia, MED Institute, Incorporated
- Responsible party
- Sponsor
- Investigators
- Jon Matsumura, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111176
- Sponsor's protocol ID
- 03-536
- Other IDs
- 37010
- Acronym
- STARZ-TX2
- Status last verified
- Aug 2014
- First submitted
- 17 May 2005
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matsumura JS, Melissano G, Cambria RP, Dake MD, Mehta S, Svensson LG, Moore RD; Zenith TX2 Clinical Trial Investigators. Five-year results of thoracic endovascular aortic repair with the Zenith TX2. J Vasc Surg. 2014 Jul;60(1):1-10. doi: 10.1016/j.jvs.2014.01.043. Epub 2014 Mar 14.
PubMed 24636714
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
- ClinicalTrials.gov ID
- NCT00111176
- Acronym / sponsor ID
- STARZ-TX2 / 03-536
- Conditions
- Thoracic Aortic Aneurysm
- Keywords
- Thoracic Aortic Aneurysm, Descending, minimally invasive, endovascular, rupture, back pain, stent graft, endovascular aneurysm repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- William Cook Europe, William Cook Australia, MED Institute, Incorporated
- Study start
- Mar 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 18 May 2005 (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.
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.
Detailed description
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2(R) TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers. Instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture.
The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Endovascular repairEndovascular Repair |
| 2 | Other | Procedure: SurgicalSurgical |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with aneurysms / ulcers of the descending thoracic aorta
- Patients who are candidates for either surgery or endovascular repair
- Patients at least 18 years old
Key exclusion criteria (6 listed)
- Age < 18 years
- Patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years)
- Patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months
- Patients unwilling or unable to comply with the follow-up schedule
- Patients unable or who refuse to give 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular repairAlso: TEVAREndovascular repair. | Device | 1 |
| SurgicalSurgical endovascular repair | Procedure or surgery | 2 |
Primary outcome
The primary hypothesis for effectiveness is that patients treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent 30-day rupture-free survival compared to the surgical control.
Time frame: 30 days
1 secondary outcome
A secondary hypothesis is subjects treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent or fewer complications compared to the surgical control group through 30 days following implant.
Time frame: 30 days
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 18 Aug 2014.
- Derived from this study: PubMed 24636714Matsumura JS, Melissano G, Cambria RP, Dake MD, Mehta S, Svensson LG, Moore RD; Zenith TX2 Clinical Trial Investigators. Five-year results of thoracic endovascular aortic repair with the Zenith TX2. J Vasc Surg. 2014 Jul;60(1):1-10. doi: 10.1016/j.jvs.2014.01.043. Epub 2014 Mar 14.
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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.
Jon Matsumura, MD principal investigator
University of Wisconsin, Madison
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular repair and Surgical in people with Thoracic Aortic Aneurysm, run by Cook Group Incorporated at 41 sites in 3 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 6 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 18 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 41 sites in United States, Canada, Italy. 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?
The primary hypothesis for effectiveness is that patients treated with the Zenith TX2(R) TAA Endovascular Graft will have equivalent 30-day rupture-free survival compared to the surgical control. (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 NCT00111176, 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 18 Aug 2014.