Study Summary
This trial is testing a new type of stent for aortic aneurysms. They will compare outcomes and quality of life measures for patients who receive this new stent to those who don't.
Eligible Conditions
- Juxtarenal Aortic Aneurysm
- Abdominal Aortic Aneurysm
- Type IV Thoracoabdominal Aortic Aneurysms
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 2 Secondary · Reporting Duration: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
12 months
Number of Subjects Who Achieve Treatment Success
30 days
Number of Subjects Who Die
Number of Subjects Who Experience a Major Adverse Event
30 days post treatment
Number of subjects who experience a Major Adverse Event at 30 days post treatment
30 days post treatment]
Number of subjects who have die at 30 days post treatment
Year 5
Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire
Trial Safety
Safety Progress
Trial Design
0 Treatment Group
200 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
Who is running the clinical trial?
Mayo ClinicLead Sponsor
2,959 Previous Clinical Trials
3,449,266 Total Patients Enrolled
3 Trials studying Aortic Aneurysm
247 Patients Enrolled for Aortic Aneurysm
Gustavo OderichLead Sponsor
1 Previous Clinical Trials
530 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
530 Patients Enrolled for Aortic Aneurysm
Cook Group IncorporatedIndustry Sponsor
91 Previous Clinical Trials
15,167 Total Patients Enrolled
15 Trials studying Aortic Aneurysm
2,849 Patients Enrolled for Aortic Aneurysm
Gustavo Oderich, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Aortic Aneurysm
102 Patients Enrolled for Aortic Aneurysm
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Kärkkäinen, Jussi M., Giuliano de A. Sandri, Emanuel R. Tenorio, Thanila A. Macedo, Janet Hofer, Peter Gloviczki, Stephen Cha, and Gustavo S. Oderich. 2019. “Prospective Assessment of Health-related Quality of Life After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using Fenestrated-branched Endografts”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2018.07.060.
- Tenorio, Emanuel R., Jussi M. Kärkkäinen, Bernardo C. Mendes, Randall R. DeMartino, Thanila A. Macedo, Alisa Diderrich, Jan Hofer, and Gustavo S. Oderich. 2020. “Outcomes of Directional Branches Using Self-expandable or Balloon-expandable Stent Grafts During Endovascular Repair of Thoracoabdominal Aortic Aneurysms”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2019.07.079.
- Oderich, Gustavo S., Emanuel R. Tenorio, Bernardo C. Mendes, Guilherme Baumgardt Barbosa Lima, Giulianna Barreira Marcondes, Naveed Saqib, Jan Hofer, Joshua Wong, and Thanila A. Macedo. 2021. “Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-branched Endografts”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000004982.
- Chait, Jesse, Emanuel R. Tenorio, Bernardo C. Mendes, Guilherme B. Barbosa Lima, Giulianna B. Marcondes, Joshua Wong, Thanila A. Macedo, Randall R. De Martino, and Gustavo S. Oderich. 2022. “Impact of Gap Distance Between Fenestration and Aortic Wall on Target Artery Instability Following Fenestrated-branched Endovascular Aortic Repair”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2022.01.135.
- Karkkainen JM, Sandri GA, Tenorio ER, Macedo TA, Hofer J, Gloviczki P, Cha S, Oderich GS. Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts. J Vasc Surg. 2019 May;69(5):1356-1366.e6. doi: 10.1016/j.jvs.2018.07.060. Epub 2018 Oct 24.
- Tenorio ER, Karkkainen JM, Mendes BC, DeMartino RR, Macedo TA, Diderrich A, Hofer J, Oderich GS. Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1489-1502.e6. doi: 10.1016/j.jvs.2019.07.079. Epub 2019 Oct 11.
- Gustavo Oderich 2013. "Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01937949.
Frequently Asked Questions
How many participants are there in this clinical trial?
"Affirmative, the information on clinicaltrials.gov affirms that this research is currently recruiting patients. This study was initially made public on August 1st 2013 and last revised on October 31st 2022. Approximatley 200 volunteers are required from a single medical center." - Anonymous Online Contributor
Unverified Answer
Are there any slots available for this research project?
"This research project is currently seeking participants; the trial was first made public on August 1, 2013 and has been edited most recently on October 31st 2022." - Anonymous Online Contributor
Unverified Answer