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Stent-Graft

Endovascular Stent-Graft for Aortic Aneurysm

N/A

Recruiting

Led By Warren J Gasper, MD

Research Sponsored by Timothy Chuter, MD

Eligibility Criteria Checklist

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

Must have

Aortic aneurysms: greater than or equal to 6 cm in diameter in men

Aortic aneurysms: greater than or equal to 5.5 cm in diameter in women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new way to treat thoracoabdominal and paravisceral abdominal aortic aneurysms by placing a stent-graft over the aneurysm.

Who is the study for?

This trial is for men and women with large aortic aneurysms (5.5 cm or more in diameter for women, 6 cm or more for men) including those that are growing quickly or have associated iliac aneurysms. Participants should expect to live at least two years, be able to consent, follow the study plan, and have suitable anatomy for the procedure. Pregnant individuals, those allergic to certain metals or materials used in stents, with uncontrolled bleeding disorders or serious infections cannot join.Check my eligibility

What is being tested?

The trial tests a new endovascular treatment using a branched stent-graft placed over thoracoabdominal and paravisceral abdominal aortic aneurysms. It aims to evaluate how safe and effective this minimally invasive operation is compared to traditional surgery.See study design

What are the potential side effects?

Potential side effects may include complications related to the placement of the stent such as blood vessel damage, infection risk at the insertion site, allergic reactions to stent materials like Nitinol or polyester, clotting issues around the graft area leading possibly leading to further interventions.

Eligibility Criteria

Inclusion Criteria

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

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I am a man with an aortic aneurysm 6 cm or larger.

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My aortic aneurysm is at least 5.5 cm wide.

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My aortic aneurysm is larger than 5 cm and growing quickly.

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I have an iliac aneurysm larger than 4 cm.

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My arteries are suitable for a minimally invasive surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Successful implantation of TAAA branched stent-graft.

Secondary outcome measures

Long term success of TAAA branched stent-graft treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionalExperimental Treatment1 Intervention

Endovascular Branched Stent-Graft: The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents).

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Timothy Chuter, MDLead Sponsor

1 Previous Clinical Trials

25 Total Patients Enrolled

Warren J Gasper, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Endovascular Branched Stent-Graft (Stent-Graft) Clinical Trial Eligibility Overview. Trial Name: NCT00483249 — N/A

Thoracoabdominal Aortic Aneurysms Research Study Groups: Interventional

Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: Endovascular Branched Stent-Graft Highlights & Side Effects. Trial Name: NCT00483249 — N/A

Endovascular Branched Stent-Graft (Stent-Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00483249 — N/A

Frequently Asked Questions

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

What is the current size of the sample population taking part in this research?

"Affirmative. According to the clinicaltrials.gov registry, this study is presently enrolling individuals. It was initially posted on May 1st 2005 and was most recently modified on July 6th 2022; it seeks 250 patients at two distinct medical sites."

Answered by AI

Are individuals being accepted for this experiment currently?

"Affirmative. The clinical trial's page on the website of clinicaltrials.gov discloses that it is actively enrolling patients, having been published in May 1st 2005 and last revised in July 6th 2022. It requires 250 participants from two medical sites to complete its objectives."

Answered by AI

Recent research and studies

European Journal of Vascular and Endovascular SurgeryJournal

Cardiovascular and Catecholamine Responses During Endovascular and Conventional Abdominal Aortic Aneurism Repair

Thompson, J.P., J.R. Boyle, M.M. Thompson, J. Strupish, P.R.F. Bell, and G. Smith. 1999. “Cardiovascular and Catecholamine Responses During Endovascular and Conventional Abdominal Aortic Aneurism Repair”. European Journal of Vascular and Endovascular Surgery. Elsevier BV. doi:10.1053/ejvs.1998.0760.

Journal of Vascular SurgeryJournal

Surgical Repair of Aneurysms Involving the Suprarenal, Visceral, and Lower Thoracic Aortic Segments: Early Results and Late Outcome

Martin, Gordon H., Patrick J. O'Hara, Norman R. Hertzer, Edward J. Mascha, Leonard P. Krajewski, Edwin G. Beven, Daniel G. Clair, and Kenneth Ouriel. 2000. “Surgical Repair of Aneurysms Involving the Suprarenal, Visceral, and Lower Thoracic Aortic Segments: Early Results and Late Outcome”. Journal of Vascular Surgery. Elsevier BV. doi:10.1067/mva.2000.106481.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

Journal of Vascular SurgeryJournal