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Device

New Aortic Repair Device for Aortic Aneurysm

N/A
Waitlist Available
Led By Patrick Kelly, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Saccular aneurysm deemed at significant risk for rupture
Proximal landing zone for the unitary manifold stent graft: Nonaneurysmal aortic segment including previously placed graft material (neck) with a minimum seal zone length of 3 cm, Diameter in the range of 19-32 mm, Iliac artery or aortic distal fixation site 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 1 year
Awards & highlights

Study Summary

This trial is testing a new device to treat thoracoabdominal aortic aneurysms. The primary goal is to assess safety and preliminary effectiveness.

Who is the study for?
Adults with thoracoabdominal aortic aneurysms that are large, growing, or at risk of rupture can join this trial. They must have specific vessel sizes and access points for the devices used in the study. Those with recent major procedures, infections, certain connective tissue disorders, allergies to device materials, kidney issues (high creatinine levels), or poor overall health cannot participate.Check my eligibility
What is being tested?
The study is testing two different devices: Visceral Manifold and Thoracic Bifurcation versus Unitary Manifold for repairing aortic aneurysms. It aims to evaluate their safety and effectiveness over time by monitoring patients who receive these treatments.See study design
What are the potential side effects?
Potential side effects may include complications related to the implantation procedure such as bleeding or infection, allergic reactions to device materials like nitinol or PTFE, blood vessel damage during insertion of the manifold or stent grafts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My aneurysm is at high risk of bursting.
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My aorta fits the size and condition requirements for a specific stent graft.
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I am 18 years old or older.
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I have a large aneurysm causing symptoms.
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My aorta near the left subclavian artery is suitable for a stent graft.
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My aneurysm grew by at least 0.5 cm in the last 6 months.
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My aneurysm is at least 5.5 cm or twice the size of the normal artery near it.
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I qualify for the primary study but have specific health issues that exclude me from it.
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My blood vessels are suitable for certain medical procedures or device insertions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from major adverse events (MAEs) at 30 days
Secondary outcome measures
Treatment success and technical success at 1 year
Treatment success at various timepoints

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary Study ArmExperimental Treatment2 Interventions
The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcation and the Visceral Manifold and the Unitary Manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.
Group II: Expanded Selection ArmExperimental Treatment2 Interventions
The expanded selection arm is for subjects not eligible for open repair or other endovascular options due to comorbidities or anatomical limitations and do not meet inclusion in the primary study arm. The Thoracic Bifurcation and the Visceral Manifold as well as the Unitary Manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Find a Location

Who is running the clinical trial?

Sanford HealthLead Sponsor
48 Previous Clinical Trials
61,673 Total Patients Enrolled
Patrick Kelly, MD4.621 ReviewsPrincipal Investigator - Sanford Health
Munroe Regional Medical Center
Medical School - New York Institute of Technology, New York College of Osteopathic Medicine, Doctor of Osteopathic Medicine
Florida Medical Center, Residency in Family Practice
5 Previous Clinical Trials
348 Total Patients Enrolled
5Patient Review
Another great visit! They are always so efficient and I appreciate that.

Media Library

Thoracoabdominal Aneurysms Research Study Groups: Primary Study Arm, Expanded Selection Arm
Unitary Manifold (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02294435 — N/A

Frequently Asked Questions

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

Are recruitment efforts for this research endeavor underway?

"Indeed, the clinical trial is enlisting volunteers. According to information on clinicaltrials.gov, this research was first posted in February 2015 and has been amended most recently on May 5th 2022."

Answered by AI

What is the participant count for this clinical experiment?

"Affirmative. According to the information stored on clinicaltrials.gov, this medical trial is currently accepting volunteers. The original post date of February 1st 2015 and last update was May 5th 2022. A total of 250 participants are needed at one location for this study."

Answered by AI
~25 spots leftby Mar 2025