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Stent-Graft

RelayPro Stent-Graft for Thoracic Aortic Aneurysm (RelayPro-A Trial)

N/A
Waitlist Available
Led By Wilson Szeto, 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 has specified disease in his/her descending thoracic aorta
Subject must be ≥ 18 years of age
Must not have
Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm
Subjects with specified compromised circulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of the RelayPro Thoracic stent-graft in people with thoracic aortic aneurysms or ulcers.

Who is the study for?
This trial is for adults over 18 with thoracic aortic aneurysms or penetrating atherosclerotic ulcers, who can consent to treatment and follow the study plan. They must have suitable anatomy for the device. Excluded are those with other types of thoracic aorta diseases, significant vessel issues, compromised circulation, certain past procedures, allergies to contrast media/device materials, pregnant women or those planning pregnancy during the study, and various specified diseases.
What is being tested?
The RelayPro Thoracic Stent-Graft's safety and effectiveness are being tested in patients with descending thoracic aorta conditions like aneurysms and ulcers. The stent-graft is designed as a minimally invasive option to repair these issues within the body's main artery.
What are the potential side effects?
While specific side effects aren't listed here, typical risks from similar procedures may include bleeding at the entry site, infection risk due to implantation of foreign material (stent), potential damage to blood vessels or organs near where the stent is placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a disease in the lower part of the artery in my chest.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have conditions like aortic dissection or ruptured aneurysm.
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I have poor blood flow in certain areas.
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I have undergone specific medical procedures.
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My blood vessels are narrowed, hardened, or twisted.
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I have a specific health condition like heart failure, stroke, or kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 6 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absence of Type I and III endoleak through 12 months;
Aneurysm
Absence of open or endovascular secondary interventions
+6 more
Secondary study objectives
Duration of hospitalization
Duration of implant procedure
Incidence of open or endovascular secondary interventions
+10 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: RelayProExperimental Treatment1 Intervention
Endovascular treatment with the investigational device.

Find a Location

Who is running the clinical trial?

Bolton MedicalLead Sponsor
16 Previous Clinical Trials
2,741 Total Patients Enrolled
Wilson Szeto, MDPrincipal InvestigatorPenn Presbyterian
3 Previous Clinical Trials
163 Total Patients Enrolled
Venkatesh Ramaiah, MDPrincipal InvestigatorArizona Heart Institute
3 Previous Clinical Trials
684 Total Patients Enrolled

Media Library

RelayPro (Stent-Graft) Clinical Trial Eligibility Overview. Trial Name: NCT02818972 — N/A
Thoracoabdominal Aortic Aneurysm Research Study Groups: RelayPro
Thoracoabdominal Aortic Aneurysm Clinical Trial 2023: RelayPro Highlights & Side Effects. Trial Name: NCT02818972 — N/A
RelayPro (Stent-Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02818972 — N/A
~13 spots leftby Jan 2026
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