RelayPro Stent-Graft for Aortic Dissection

Recruiting in Palo Alto (17 mi)

+32 other locations

Christian Charles Shults, MD| Valvular ...

Overseen ByEd Y Woo, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Bolton Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

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

My arteries are suitable for a specific medical device insertion.

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

Exclusion Criteria

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

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

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

I have severe heart failure (NYHA class IV).

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

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

I need daily oxygen therapy at home.

I have kidney problems but am not on dialysis.

My blood pressure and heart rate are not stable.

I need surgery for an aneurysm in my aorta.

I have an ongoing infection or fungal aneurysm.

I have had dead bowel tissue.

I have unstable chest pain due to heart disease.

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

Participant Groups

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.

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.