What side effects are associated with this type of intervention?

Common side effects of endovascular repair for aortic dissection, such as those involving RelayPro Thoracic Endografts, include endoleak, stent migration, device infolding or collapse, and aortoesophageal fistula. Patients may also develop pleural effusions. These complications can necessitate additional medical interventions.

What prior FDA approvals exist?

The FDA has approved several endovascular stent-grafts for the treatment of aortic dissection, which provide structural support to stabilize the aorta. Notable examples include the Gore TAG Thoracic Endoprosthesis and the Medtronic Valiant Thoracic Stent Graft. These devices are designed to reinforce the weakened section of the aorta, preventing rupture and promoting healing. The RelayPro Thoracic Endografts, currently under study, are similar in function, aiming to provide a minimally invasive option for managing acute, complicated type B aortic dissections.

What other types of research exist?

Promising alternatives to RelayPro Thoracic Endografts for aortic dissection treatment include: 1) Scalloped stent-grafts, which have shown high technical success and low complication rates, particularly for preserving left subclavian artery flow. 2) The RELAY NBS PLUS stent-graft, which has demonstrated safety and efficacy in treating aortic arch pathology. 3) The use of distal bare-metal stents in combination with TEVAR, which has shown improved remodeling outcomes in acute complicated type B dissections.

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Stent-Graft

RelayPro Stent-Graft for Aortic Dissection

N/A

Waitlist Available

Led By Christian Shults, 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 an acute (symptom onset to diagnosis within 2 weeks) or subacute, complicated type B aortic dissection confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with malperfusion of the viscera, kidneys, spinal cord, or lower extremities, rupture, or intractable pain

Proximal and distal aortic neck with diameter between 19 mm and 42 mm

Must not have

Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment date

Diagnosis of traumatic injury or transection of the descending thoracic aorta

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 6, and 12 month follow-up visits, and annually through 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called RelayPro to help patients with severe tears in their main artery. The device supports the artery from the inside, helping it heal and preventing further damage. RelayPro is a second-generation, low-profile thoracic endograft developed by Terumo Aortic, designed for treating thoracic aortic aneurysm or penetrating atherosclerotic ulcer.

Who is the study for?

This trial is for individuals with a recent (within 6 weeks) and severe type B aortic dissection, confirmed by imaging tests. Participants must have specific complications like organ malperfusion or rupture, suitable vascular access for the device, and an anatomy that fits the stent-graft requirements. Exclusions include prior major surgeries in affected areas, unstable heart conditions, severe lung disease requiring oxygen therapy, acute kidney failure not on dialysis, extreme obesity affecting imaging quality, among others.

What is being tested?

The RelayPro Thoracic Stent-Graft system is being tested in patients with acute complicated type B aortic dissection. The study is prospective and non-randomized to evaluate if this stent can effectively treat the condition while monitoring all-cause mortality within 30 days after the procedure.

What are the potential side effects?

While specific side effects are not listed here, typical risks of stent-grafts may include bleeding at the entry site; movement or misplacement of the stent; injury to blood vessels; blood clots; infection; allergic reactions to materials used in the graft.

Eligibility Criteria

Inclusion Criteria

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

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My aortic dissection was diagnosed within 6 weeks of symptom onset and is causing severe complications.

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The diameter of my aortic neck is between 19 mm and 42 mm.

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My arteries are suitable for a specific medical device insertion.

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My body's structure fits the specific requirements for the treatment.

Exclusion Criteria

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

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

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I have had a traumatic injury to the main artery in my chest.

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My blood vessels are not suitable for certain medical device placements.

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I have severe heart failure (NYHA class IV).

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I have had surgery or a procedure on the main artery in my chest.

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I had surgery for an abdominal aortic aneurysm less than 6 months ago.

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I need daily oxygen therapy at home.

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I have kidney problems but am not on dialysis.

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My blood pressure and heart rate are not stable.

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I need surgery for an aneurysm in my aorta.

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I have an ongoing infection or fungal aneurysm.

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I have had dead bowel tissue.

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I have unstable chest pain due to heart disease.

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My treatment plan may affect blood flow to major arteries in my neck or stomach area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 6, and 12 month follow-up visits, and annually through 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 6, and 12 month follow-up visits, and annually through 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, and 12 month follow-up visits, 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

All-cause mortality post-procedure

Secondary study objectives

Tissue Dissection

Technical Success at the time of the index procedure

Treatment success through 1 month

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: Experimental: Relay ProExperimental Treatment1 Intervention

The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for aortic dissection, especially acute and complicated cases, is thoracic endovascular aortic repair (TEVAR). TEVAR involves the insertion of a stent-graft into the aorta via a catheter, which is typically introduced through the femoral artery. The stent-graft provides structural support to the weakened or torn section of the aorta, preventing further dissection and promoting healing by re-establishing normal blood flow. This minimally invasive approach reduces the risk of rupture and other complications compared to open surgical repair. For patients, this means a potentially lower risk of mortality and morbidity, quicker recovery times, and fewer complications, making it a critical option in the management of aortic dissection.