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Stent Graft

Fenestrated Stent Graft for Abdominal Aortic Aneurysm (IDE#1 Trial)

N/A

Recruiting

Led By Gustavo Oderich, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aneurysm with a history of growth ≥ 0.5 cm per year

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.

Awards & highlights

IDE#1 Trial 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.

Who is the study for?

This trial is for adults with complex abdominal aortic aneurysms, specifically juxtarenal, suprarenal, or type IV thoracoabdominal types that are at high risk of rupture. Candidates should have aneurysms ≥5.0 cm or twice the normal size, or those growing ≥0.5 cm per year. Excluded are individuals under 18, pregnant/breastfeeding women, those unwilling to follow up, with less than 2 years life expectancy or other medical/anatomical restrictions.Check my eligibility

What is being tested?

The study tests the effectiveness and quality of life impact of using custom-made Cook Zenith® Fenestrated AAA Endovascular Grafts in repairing complex abdominal aortic aneurysms close to the kidneys and above.See study design

What are the potential side effects?

While not specified here, endovascular graft procedures can generally lead to side effects such as bleeding at the access site, infection, blood vessel damage near the graft and potential issues related to kidney function due to proximity.

IDE#1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My aneurysm has grown at least 0.5 cm in a year.

IDE#1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects who experience a Major Adverse Event at 30 days post treatment

Number of subjects who have die at 30 days post treatment

Secondary outcome measures

Number of Subjects Who Achieve Treatment Success

Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire

IDE#1 Trial Design

1Treatment groups

Experimental Treatment

Group I: EndovascularExperimental Treatment1 Intervention

The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. Other names: Endovascular stent Stent-graft

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,210 Previous Clinical Trials

3,766,773 Total Patients Enrolled

4 Trials studying Aortic Aneurysm

297 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

15,312 Total Patients Enrolled

15 Trials studying Aortic Aneurysm

2,994 Patients Enrolled for Aortic Aneurysm

Media Library

Custom-made Zenith® Fenestrated AAA Endovascular Graft (Stent Graft) Clinical Trial Eligibility Overview. Trial Name: NCT01937949 — N/A

Aortic Aneurysm Research Study Groups: Endovascular

Aortic Aneurysm Clinical Trial 2023: Custom-made Zenith® Fenestrated AAA Endovascular Graft Highlights & Side Effects. Trial Name: NCT01937949 — N/A

Custom-made Zenith® Fenestrated AAA Endovascular Graft (Stent Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01937949 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Recent research and studies

Journal of Vascular SurgeryJournal

Prospective Assessment of Health-related Quality of Life After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using Fenestrated-branched Endografts

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.

Journal of Vascular SurgeryJournal

Outcomes of Directional Branches Using Self-expandable or Balloon-expandable Stent Grafts During Endovascular Repair of Thoracoabdominal Aortic Aneurysms

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.

Annals of SurgeryJournal

Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-branched Endografts

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.

Journal of Vascular SurgeryJournal