Thoracoabdominal AneurysmNCT00583050
Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts
A study testing Endovascular Aneurysm Repair in people with Thoracoabdominal Aneurysm and Abdominal Aortic Aneurysm, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aneurysm, Abdominal Aortic Aneurysm
- What is being tested?
- Endovascular Aneurysm Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,366 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to 1 Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Not pregnant
- Willing and able to comply with two-year follow-up period.
- Willing and able to give informed consent prior to enrollment
- No known allergy to stainless steel or polyester
- No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
- Life expectancy greater than two years
- High risk candidate for open surgical repair
Who cannot join
- see above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.
Read the detailed description
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.
- Being tested
- Endovascular Aneurysm Repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aneurysm RepairDevice
Also called Cook Zenith
Endovascular exclusion of aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Aneurysm Repair | Experimental | Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts Receives: Device: Endovascular Aneurysm Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Aneurysm Rupture
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startFeb 2001
- Primary completion31 Dec 2019
- Study completion1 Feb 2020
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.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal AneurysmStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 1,366 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Behzad Farivar, M. D., The Cleveland Clinic
- Investigators
- Behzad Farivar, M. D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583050
- Sponsor's protocol ID
- G010002
- Other IDs
- IRB 4281
- Status last verified
- Apr 2020
- First submitted
- 20 Dec 2007
- Last updated
- 8 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang J, Brier C, Parodi FE, Kuramochi Y, Lyden SP, Eagleton MJ. Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 Oct;72(4):1360-1366. doi: 10.1016/j.jvs.2019.12.040. Epub 2020 Mar 12.
PubMed 32173192Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.
PubMed 26792544Sylvan J, Brier C, Wolski K, Yanof J, Goel V, Kuramochi Y, Eagleton MJ. Impact of alterations in target vessel curvature on branch durability after endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Mar;63(3):634-41. doi: 10.1016/j.jvs.2015.09.053. Epub 2015 Nov 29.
PubMed 26620715Mastracci TM, Eagleton MJ, Kuramochi Y, Bathurst S, Wolski K. Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms. J Vasc Surg. 2015 Feb;61(2):355-64. doi: 10.1016/j.jvs.2014.09.068.
PubMed 25619574O'Callaghan A, Greenberg RK, Eagleton MJ, Bena J, Mastracci TM. Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality. J Vasc Surg. 2015 Apr;61(4):908-14. doi: 10.1016/j.jvs.2014.10.085. Epub 2015 Jan 16.
PubMed 25600335O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia. J Vasc Surg. 2015 Feb;61(2):347-354.e1. doi: 10.1016/j.jvs.2014.09.011. Epub 2014 Oct 23.
PubMed 25449006O'Callaghan A, Mastracci TM, Greenberg RK, Eagleton MJ, Bena J, Kuramochi Y. Outcomes for supra-aortic branch vessel stenting in the treatment of thoracic aortic disease. J Vasc Surg. 2014 Oct;60(4):914-20. doi: 10.1016/j.jvs.2013.12.053. Epub 2014 Jul 1.
PubMed 24993951Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1.
PubMed 24188715Mohapatra A, Greenberg RK, Mastracci TM, Eagleton MJ, Thornsberry B. Radiation exposure to operating room personnel and patients during endovascular procedures. J Vasc Surg. 2013 Sep;58(3):702-9. doi: 10.1016/j.jvs.2013.02.032. Epub 2013 Jun 28.
PubMed 23810300Brown CR, Greenberg RK, Wong S, Eagleton M, Mastracci T, Hernandez AV, Rigelsky CM, Moran R. Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives. J Vasc Surg. 2013 Sep;58(3):573-81. doi: 10.1016/j.jvs.2013.02.239. Epub 2013 Jul 1.
PubMed 23809203Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM, Roselli EE. Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms. J Vasc Surg. 2013 Sep;58(3):625-34. doi: 10.1016/j.jvs.2013.01.049. Epub 2013 Jun 22.
PubMed 23800455Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.
PubMed 23611709Mastracci TM, Greenberg RK, Eagleton MJ, Hernandez AV. Durability of branches in branched and fenestrated endografts. J Vasc Surg. 2013 Apr;57(4):926-33; discussion 933. doi: 10.1016/j.jvs.2012.09.071. Epub 2013 Feb 20.
PubMed 23433817
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts
- ClinicalTrials.gov ID
- NCT00583050
- Acronym / sponsor ID
- G010002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,366 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Feb 2001 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 8 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.
Detailed description
The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Aneurysm Repair | Experimental | Device: Endovascular Aneurysm RepairEndovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age.
- Not pregnant
- Willing and able to comply with two-year follow-up period.
- Willing and able to give informed consent prior to enrollment
- No known allergy to stainless steel or polyester
Key exclusion criteria (1 listed)
- see above
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 Aneurysm RepairAlso: Cook ZenithEndovascular exclusion of aneurysm | Device | Endovascular Aneurysm Repair |
Primary outcome
Freedom From Aneurysm Rupture
Time frame: 2 years
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32173192Zhang J, Brier C, Parodi FE, Kuramochi Y, Lyden SP, Eagleton MJ. Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 Oct;72(4):1360-1366. doi: 10.1016/j.jvs.2019.12.040. Epub 2020 Mar 12.
- Derived from this study: PubMed 26792544Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.
- Derived from this study: PubMed 26620715Sylvan J, Brier C, Wolski K, Yanof J, Goel V, Kuramochi Y, Eagleton MJ. Impact of alterations in target vessel curvature on branch durability after endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Mar;63(3):634-41. doi: 10.1016/j.jvs.2015.09.053. Epub 2015 Nov 29.
- Derived from this study: PubMed 25619574Mastracci TM, Eagleton MJ, Kuramochi Y, Bathurst S, Wolski K. Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms. J Vasc Surg. 2015 Feb;61(2):355-64. doi: 10.1016/j.jvs.2014.09.068.
- Derived from this study: PubMed 25600335O'Callaghan A, Greenberg RK, Eagleton MJ, Bena J, Mastracci TM. Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality. J Vasc Surg. 2015 Apr;61(4):908-14. doi: 10.1016/j.jvs.2014.10.085. Epub 2015 Jan 16.
- Derived from this study: PubMed 25449006O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia. J Vasc Surg. 2015 Feb;61(2):347-354.e1. doi: 10.1016/j.jvs.2014.09.011. Epub 2014 Oct 23.
- Derived from this study: PubMed 24993951O'Callaghan A, Mastracci TM, Greenberg RK, Eagleton MJ, Bena J, Kuramochi Y. Outcomes for supra-aortic branch vessel stenting in the treatment of thoracic aortic disease. J Vasc Surg. 2014 Oct;60(4):914-20. doi: 10.1016/j.jvs.2013.12.053. Epub 2014 Jul 1.
- Derived from this study: PubMed 24188715Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1.
- Derived from this study: PubMed 23810300Mohapatra A, Greenberg RK, Mastracci TM, Eagleton MJ, Thornsberry B. Radiation exposure to operating room personnel and patients during endovascular procedures. J Vasc Surg. 2013 Sep;58(3):702-9. doi: 10.1016/j.jvs.2013.02.032. Epub 2013 Jun 28.
- Derived from this study: PubMed 23809203Brown CR, Greenberg RK, Wong S, Eagleton M, Mastracci T, Hernandez AV, Rigelsky CM, Moran R. Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives. J Vasc Surg. 2013 Sep;58(3):573-81. doi: 10.1016/j.jvs.2013.02.239. Epub 2013 Jul 1.
- Derived from this study: PubMed 23800455Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM, Roselli EE. Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms. J Vasc Surg. 2013 Sep;58(3):625-34. doi: 10.1016/j.jvs.2013.01.049. Epub 2013 Jun 22.
- Derived from this study: PubMed 23611709Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. doi: 10.1016/j.jvs.2012.12.087. Epub 2013 Apr 20.
- 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.
Behzad Farivar, M. D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Aneurysm Repair in people with Thoracoabdominal Aneurysm and Abdominal Aortic Aneurysm, run by The Cleveland Clinic at 1 site 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 8 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 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 May 2020). 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?
Freedom From Aneurysm Rupture (time frame: 2 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 NCT00583050, which also lists 13 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 8 May 2020.