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Stent Graft System

Stent Graft System for Thoracoabdominal Aortic Aneurysm

N/A

Waitlist Available

Led By Murray Shames, MD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

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

Must have

Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)

Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of a new kind of medical device to treat aortic aneurysms. The device has been shown to be effective in prior clinical studies, and the investigators believe it is safe to use in a larger group of patients.

Who is the study for?

This trial is for adults over 18 with thoracic aortic aneurysms at risk of rupture, symptomatic aneurysms larger than 4.5 cm, or certain types of dissections. Candidates must have specific anatomical features that fit the device's requirements and cannot be good candidates for open surgery or other available endovascular prostheses.Check my eligibility

What is being tested?

The study tests a TAAA Debranching Stent Graft System designed to treat complex aortic aneurysms. It aims to collect preliminary safety data and assess device functionality in a small group of patients to minimize risk while gathering valuable information.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include complications related to stent graft systems such as blood vessel damage, bleeding, infection, clotting within the stent (thrombosis), misplacement of the device, and possible impact on kidney function due to contrast media used during implantation.

Eligibility Criteria

Inclusion Criteria

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

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I have major issues with two of my body's systems like heart or lungs.

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My iliac artery or aorta has a secure attachment site that's at least 15 mm long and 8-25 mm wide.

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My aneurysm is at high risk of bursting.

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I have a large aneurysm causing symptoms.

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My blood vessels are suitable for certain medical procedures or device insertions.

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I have had a ruptured aneurysm.

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I have a type B dissection in the part of my aorta needing treatment.

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My aorta near the left shoulder has a healthy section at least 2.5 cm long and is 26-42 mm wide.

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I am 18 years old or older.

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I have a contained rupture.

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My aneurysm grew more than 0.5 cm in 6 months.

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My anatomy allows for keeping at least one hypogastric artery intact.

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I qualify for the main study but have a blood vessel smaller than 5 mm.

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My anatomy prevents proper blood flow in my left subclavian artery.

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

Proportion of subjects free from major adverse events

Secondary outcome measures

Proportion of subjects free from individual components of primary safety endpoint

Proportion of subjects free from paraparesis

Proportion of subjects with technical success

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Primary studyExperimental Treatment1 Intervention

Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System.

Group II: Expanded selectionExperimental Treatment1 Intervention

Patients who fail to meet inclusion criteria for the primary study arm may be enrolled under the expanded selection arm and be treated with the TAAA Debranching Stent Graft System.

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor

412 Previous Clinical Trials

187,044 Total Patients Enrolled

MedtronicIndustry Sponsor

607 Previous Clinical Trials

828,660 Total Patients Enrolled

2 Trials studying Thoracoabdominal Aortic Aneurysms

19 Patients Enrolled for Thoracoabdominal Aortic Aneurysms

Sanford HealthOTHER

48 Previous Clinical Trials

61,908 Total Patients Enrolled

1 Trials studying Thoracoabdominal Aortic Aneurysms

15 Patients Enrolled for Thoracoabdominal Aortic Aneurysms

Media Library

TAAA Debranching Stent Graft System (Stent Graft System) Clinical Trial Eligibility Overview. Trial Name: NCT03075748 — N/A

Thoracoabdominal Aortic Aneurysms Research Study Groups: Primary study, Expanded selection

Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: TAAA Debranching Stent Graft System Highlights & Side Effects. Trial Name: NCT03075748 — N/A

TAAA Debranching Stent Graft System (Stent Graft System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03075748 — 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 cap on enrollment for this scientific investigation?

"Affirmative. The clinicaltrials.gov website lists this trial as currently recruiting participants, with the initial posting date of December 19th 2017 and a recent edit on September 28th 2021. This research requires 15 volunteers between 2 different medical sites."

Answered by AI

Is the recruitment process currently open to participants?

"Indeed, clinicaltrials.gov reveals that this clinical trial is currently searching for volunteers; the original posting date was December 19th 2017 and it has since been updated on September 28 2021. Altogether, 15 participants are needed from 2 separate sites."

Answered by AI

Recent research and studies

Journal of Vascular SurgeryJournal

A Novel Endovascular Debranching Technique Using Physician-assembled Endografts for Repair of Thoracoabdominal Aneurysms

Anderson, Joe, Madeline Nykamp, Laura Danielson, Tyler Remund, and Patrick W. Kelly. 2014. “A Novel Endovascular Debranching Technique Using Physician-assembled Endografts for Repair of Thoracoabdominal Aneurysms”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2014.05.090.

VascularJournal

Complete Endovascular Debranching of the Aortic Arch: A Report of Two Cases

Anderson, Joseph, Madeline Nykamp, Tyler Remund, and Patrick Kelly. 2014. “Complete Endovascular Debranching of the Aortic Arch: A Report of Two Cases”. Vascular. SAGE Publications. doi:10.1177/1708538114542174.

Journal of Vascular SurgeryJournal

Stent Graft Modification with Mini-cuff Reinforced Fenestrations for Urgent Repair of Thoracoabdominal Aortic Aneurysms

Oderich, Gustavo S., Javairiah Fatima, and Peter Gloviczki. 2011. “Stent Graft Modification with Mini-cuff Reinforced Fenestrations for Urgent Repair of Thoracoabdominal Aortic Aneurysms”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2011.06.023.

Annals of Vascular SurgeryJournal