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Stent Graft System

Stent Graft for Aortic Aneurysm

N/A

Recruiting

Led By Geoffrey Answini, MD

Research Sponsored by The Christ Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Anatomy that would not allow primary or assisted patency of the left subclavian artery

Anatomy that would not allow maintenance of at least one patent hypogastric artery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new device to treat thoracoabdominal aortic aneurysms. The primary goals are to assess safety and preliminary effectiveness of the device.

Who is the study for?

This trial is for adults over 18 with thoracoabdominal aortic aneurysms larger than 5.5 cm or growing quickly, at risk of rupture, or symptomatic. Candidates must have suitable anatomy for the stent graft and expect to live more than a year but can't be pregnant, breastfeeding, allergic to device materials like nitinol or polyester, have severe infections, kidney issues (creatinine >2.0 mg/dL), unmanageable blood clotting disorders, certain connective tissue diseases, or be unsuitable for X-ray imaging.

What is being tested?

The Medtronic Valiant Thoracoabdominal Stent Graft System is being tested in patients with specific types of aortic aneurysms. The study aims to evaluate the safety and initial effectiveness of this device by monitoring technical and treatment success over time after implantation.

What are the potential side effects?

While not explicitly listed here, potential side effects may include complications related to the implant such as infection risks around the stent area; bleeding due to anticoagulation; allergic reactions; damage to surrounding organs or vessels; blockage within the stent; movement of the stent from its original position.

Eligibility Criteria

Exclusion Criteria

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

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

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My body's structure allows for at least one open hypogastric artery.

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I have major issues with two of my body systems like heart, kidneys, liver, or muscles.

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My body size may prevent clear x-ray images or is too large for the equipment.

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I can be treated with a standard, approved vascular device.

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My condition involves a contained rupture.

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I have a tear in the treated part of my aorta.

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I have a blood clotting disorder that cannot be corrected.

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I have had a major surgery not related to aneurysm treatment within the last 30 days.

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I am not willing to follow the required follow-up schedule.

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I cannot or do not want to give permission for treatment.

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I am allergic or react badly to blood thinners or dye used in imaging tests.

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I have unstable chest pain.

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I have had a ruptured aneurysm.

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I have had a stent placed in one of my body's main blood vessels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

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

Proportion of subjects free from major adverse events

Secondary study objectives

Treatment Success at follow-up intervals

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Primary Study ArmExperimental Treatment1 Intervention

Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

Group II: Expanded Selection ArmExperimental Treatment1 Intervention

Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

0 / 15Eligibility criteria met