Thoracic Stent-Graft for Aortic Aneurysm

(RelayBranch Trial)

Not currently recruiting at 12 trial locations

Overseen By Valerie DePetrillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Must not be taking: Anticoagulants

Disqualifiers: Stroke, Myocardial infarction, Severe CHF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new device called the RelayBranch Thoracic Stent-Graft System to determine its safety and effectiveness for individuals with specific aortic issues. The trial targets those with aortic aneurysms (a bulging artery), ulcers, or uncomplicated tears in the aorta. It suits individuals needing a device that covers critical arteries. Participants will assist researchers in assessing the device's functionality and identifying any necessary modifications. As an unphased trial, this study allows participants to contribute to pioneering research that could lead to innovative solutions for aortic conditions.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on blood thinners or have a bleeding disorder, you may need to stop them for a week before and after the procedure. It's best to discuss your specific medications with the study team.

What prior data suggests that the Relay Branch System is safe for treating aortic aneurysms?

Research shows that the RelayBranch Thoracic Stent-Graft System is undergoing testing for its safety in treating aortic aneurysms, which are bulges in the wall of the aorta, the body's largest artery. Previous studies on similar devices, like the RelayPro, found low rates of complications during and after surgery. This evidence supports the safety of using these stent-grafts for conditions affecting the thoracic aorta.

Although the current study remains in its early stages and more information is needed, earlier devices from the same family have shown promise. They have generally been well-tolerated by patients, with most experiencing no serious side effects. This provides some confidence in the safety of the RelayBranch System. However, as this is an early feasibility study, complete safety data are still being collected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RelayBranch Thoracic Stent-Graft System is unique because it offers a specialized way to treat aortic aneurysms, a condition where the main blood vessel from the heart bulges dangerously. Unlike traditional open surgery or standard endovascular repair, this system is designed to cater specifically to complex cases, including those with aneurysmal disease, penetrating atherosclerotic ulcers, and chronic uncomplicated Type B aortic dissections. Researchers are excited about this treatment because it allows for a less invasive approach, potentially reducing recovery time and improving outcomes for patients with these challenging conditions.

What evidence suggests that this device is effective for aortic aneurysm?

Research has shown that the RelayBranch Thoracic Stent-Graft System, which participants in this trial will receive, could be a promising treatment for thoracic aortic aneurysms, a serious condition where the main artery wall bulges out. Studies have found that stent-grafts like this one can effectively repair these aneurysms by strengthening the weakened part of the artery. Early results from similar devices suggest they help maintain normal blood flow and prevent further damage. This system offers a new option for patients with these conditions, focusing on both safety and effectiveness. While more information is needed, its mechanism and initial results are encouraging. ^{1 2 3 5 6}

Who Is on the Research Team?

Luis Sanchez, M.D

Principal Investigator

Barnes Jewish Hospital, Washington Univ

Wilson Szeto, MD

Principal Investigator

Penn Presbyterian Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with specific types of aortic aneurysms or penetrating ulcers in the ascending aorta, arch, or proximal descending thoracic aorta. Candidates must have anatomy suitable for the stent-graft system and be willing to follow up after treatment. Exclusions include severe allergies to device materials, certain heart and lung conditions, recent major procedures, systemic infections, renal failure, and other investigational study involvement.

Inclusion Criteria

My treatment would involve covering key arteries near my heart with a graft.

There are specific rules for where the graft attaches to the arch of the blood vessel.

Your blood vessels need to be a certain size and length for the study.

Exclusion Criteria

The area where the graft needs to be placed is too close to important blood vessels.

I am on blood thinners for a heart rhythm problem or a clotting disorder.

My blood pressure and heart rate are unstable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Index Procedure

Assessment of the safety and effectiveness of the Relay Branch System during the initial procedure

1 day

1 visit (in-person)

30-day Follow-up

Evaluation of device patency and technical success 30 days post-operation

4 weeks

1 visit (in-person)

90-day Follow-up

Assessment of major adverse events including mortality, stroke, and other complications

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• RelayBranch Thoracic Stent-Graft System

Trial Overview The RelayBranch Thoracic Stent-Graft System is being tested for safety and effectiveness in treating thoracic aortic aneurysms. The trial involves implanting this device into patients' affected arteries and monitoring them closely at initial deployment and again after 30 days to assess how well it works.

How Is the Trial Designed?

Group I: Relay Branch System Experimental Treatment 1 Intervention

Subjects who receive the Relay Branch System for repair which includes those with aneurysmal disease, penetrating atherosclerotic ulcer (PAU), and chronic uncomplicated Type B aortic dissection.

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03214601

Early Feasibility Study of the RelayBranch Thoracic Stent ... The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03214601?tab=history&a=1

Early Feasibility Study of the RelayBranch Thoracic Stent-Graft ... The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies. Other Names: Relay ...

3. umms.org umms.org/ummc/pros/physician-briefs/heart-vascular/aortic-disease-hypertension/forefront-of-innovation-in-or-with-trial-research

UM Center for Aortic Disease at the Forefront of Innovation ... In this trial, the TBE device will be used to repair zone 0/1 aortic aneurysms (arm 1) and non-aneurysm lesions, including dissections and intramural hematomas ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521420313537

Clinical research study Thoracic endovascular aortic repair ... Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9277010/

RELAYTM Branched–International Results of Vessel ... The RELAY™ branched system is indicated for on-label use in patients with thoracic aortic aneurysms (TAAs) and penetrating atherosclerotic ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045S002B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Relay®Pro Thoracic Stent-Graft System (referred to as RelayPro hereafter) is designed to treat fusiform aneurysms and saccular aneurysms/ ...