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Stent-Graft

Thoracic Stent-Graft for Thoracic Aortic Injury

N/A

Waitlist Available

Led By Ben Starnes, MD

Research Sponsored by Bolton Medical

Eligibility Criteria Checklist

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

Must have

Subject must have a proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery

Age greater than 18 years

Must not have

Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal, aorta requiring repair

Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 6 months, 12 months, and annually through 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the safety and effectiveness of a new device to treat people who have suffered a traumatic injury to their descending thoracic aorta.

Who is the study for?

This trial is for adults over 18 with a recent traumatic injury to the descending thoracic aorta. Candidates must have specific aortic dimensions, be willing to follow up, and consent to treatment. Exclusions include severe artery issues, other major heart or lung conditions, allergies to device materials, recent stroke or heart attack, chronic kidney failure not on dialysis, life expectancy under two years, certain anatomical variants affecting blood flow after device placement.

What is being tested?

The study tests the Relay Pro Thoracic Stent-Graft System's safety and effectiveness in repairing traumatic injuries of the descending thoracic aorta. Participants will receive this stent-graft system and their recovery and outcomes will be monitored.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include complications at insertion sites such as bleeding or infection; allergic reactions; migration of the stent; damage to surrounding vessels or tissues; clotting issues leading to stroke or limb ischemia.

Eligibility Criteria

Inclusion Criteria

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

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My aorta's affected area is between my neck artery and the artery to my stomach.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery for an aneurysm in my chest or abdomen.

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I have a bleeding or clotting disorder that can't be paused for surgery.

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I have severe heart failure.

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I have not had a stroke or heart attack in the last 3 months.

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I need daily oxygen therapy at home.

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I have an ongoing infection or fungal aneurysm.

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My blood vessels at the intended device site are not suitable for a secure device placement.

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My blood pressure and heart rate are not stable.

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My treatment involves covering arteries in my neck or abdomen that cannot be fixed with surgery.

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I have had surgery or a procedure in my descending thoracic aorta without any grafts placed.

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I have unstable chest pain due to heart disease.

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I have kidney problems but am not on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 6 months, 12 months, and annually through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 6 months, 12 months, and annually through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 months, 12 months, and annually through 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mortality post-procedure

Secondary study objectives

All-cause mortality

Aortic expansion

Aortic rupture

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Relay Pro Thoracic Stent-Graft SystemExperimental Treatment1 Intervention

The Relay Pro arm includes subjects who receive the device to treat traumatic injury of the descending thoracic aorta with the RelayPro Thoracic Stent-Graft System

0 / 14Eligibility criteria met