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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 6 months and 12 months
Awards & highlights

RelayPro-A Trial 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.Check my eligibility
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.See study design
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.

RelayPro-A Trial Eligibility Criteria

Inclusion Criteria

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

RelayPro-A Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absence of Type I and III endoleak through 12 months;
Aneurysm
Absence of open or endovascular secondary interventions
+6 more
Secondary outcome measures
Duration of hospitalization
Duration of implant procedure
Incidence of open or endovascular secondary interventions
+10 more

RelayPro-A 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
15 Previous Clinical Trials
2,506 Total Patients Enrolled
Wilson Szeto, MDPrincipal InvestigatorPenn Presbyterian
3 Previous Clinical Trials
123 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
Thoracic Aortic Aneurysm Research Study Groups: RelayPro
Thoracic 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this clinical experiment?

"Discerning the information available on clinicaltrials.gov, it is apparent that participant recruitment for this trial has ceased. Initially posted in May of 2017 and last updated in 2022, no new patients are being considered at this time; however there are 487 other studies still considering participants."

Answered by AI

What primary objectives is this experiment attempting to attain?

"As described by the clinical trial sponsor, Bolton Medical, the primary outcome measured over a year-long period is stent graft patency. Furthermore, secondary outcomes including vascular access complications during treatment visits and endoleaks of all types will be observed along with rate of stent-graft migration (> 10 mm)."

Answered by AI

How many medical centers are running this testing protocol?

"This trial is currently hosted by 15 locations, including Cleveland, Philadelphia and Hartford. To minimize the amount of travelling required for patients enrolled in this study, it is recommended to choose a site nearest you."

Answered by AI
~14 spots leftby Mar 2025