RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro-A)

May 28, 2025 updated by: Bolton Medical

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hiroshima, Japan
        • Hiroshima University Hospital
    • Aichi
      • Nagoya, Aichi, Japan
        • Nagoya University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Teine Keihinkai Hospital
    • Nara
      • Kashihara, Nara, Japan
        • Nara Medical University Hospital
    • Niigata
      • Niigata City, Niigata, Japan
        • Niigata University Medical & Dental Hospital
    • Oita
      • Yufu City, Oita, Japan
        • Oita University Hospital
    • Osaka
      • Joto-ku, Osaka, Japan
        • Morinomiya Hospital
      • Suita, Osaka, Japan
        • National Cerebral & Cardiovascular Center
    • Saitama
      • Ōmiya, Saitama, Japan
        • Jichi Medical University Saitama Medical Center
    • Tokyo
      • Minato-Ku, Tokyo, Japan
        • Jikei University Hospital
      • Shinjuku-Ku, Tokyo, Japan
        • Keio University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama-Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Institute
    • California
      • Irvine, California, United States, 92868
        • University of California, Irvine
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Hospital
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Heart Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center / Harvard Medical School
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center / Penn Presbyterian
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Centennial Heart & Vascular Institute Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Medical Center - Plano The Heart Hospital
      • Temple, Texas, United States, 76508
        • Baylor Scot & White Medical Center - Temple

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject must be ≥ 18 years of age
  • Subject has specified disease in his/her descending thoracic aorta.
  • Subject have anatomical compliance for the device specified for both access vessels and treatment area.
  • Subject must be willing to comply with the follow-up evaluation schedule.
  • Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.

Exclusion Criteria:

  • 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.
  • Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
  • Subjects with specified compromised circulation.
  • Subjects with specified prior procedures.
  • Subjects with allergy to contrast media or device components.
  • Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
  • Subjects that are pregnant or planning to become pregnant during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RelayPro
Endovascular treatment with the investigational device.
Device: RelayPro
Endovascular treatment with investigational device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Events (MAEs)
Time Frame: 30 days

Primary safety endpoint is a composite of the following MAEs occurring through 30 days:

  • Death
  • Stroke (excluding transient ischemic attack)
  • Paralysis (excludes paraparesis)
30 days
Technical success
Time Frame: 24 hours

Primary effectiveness rate as measured by the technical success through 24 hours, defined as:

  • Successful delivery of the device through the vasculature;
  • Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
24 hours
Stent graft patency
Time Frame: 12 months
Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
12 months
Aneurysm rupture
Time Frame: 12 months
Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
12 months
Absence of Type I and III endoleak through 12 months;
Time Frame: 12 months
Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
12 months
Absence of stent fractures in the attachment zone through 12 months
Time Frame: 12 months
Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
12 months
Absence of open or endovascular secondary interventions
Time Frame: 12 months
Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
12 months
Absence of aneurysm expansion (> 5 mm diameter increase)
Time Frame: 12 months
Primary effectiveness as measured by the absence of aneurysm expansion (> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
12 months
Absence of stent-graft migration
Time Frame: 12 months
Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Loss of stent-graft patency
Time Frame: 1 month and 6 months
Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.
1 month and 6 months
Rate of aneurysm rupture
Time Frame: 1 month and 6 months
The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.
1 month and 6 months
Rate of endoleaks of all types
Time Frame: 1 month, 6 months and 12 months
Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.
1 month, 6 months and 12 months
Rate of stent fractures in the attachment zone
Time Frame: 1 month and 6 months
Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media.
1 month and 6 months
Incidence of open or endovascular secondary interventions
Time Frame: 1 month and 6 months
Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).
1 month and 6 months
Rate of aneurysm expansion
Time Frame: 1 month and 6 months
The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT
1 month and 6 months
Rate of stent-graft migration
Time Frame: 1 month and 6 months
The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.
1 month and 6 months
Individual outcomes of composite MAEs
Time Frame: 6 months and 12 months
Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss >1,000 cc.
6 months and 12 months
Rate of vascular access complications
Time Frame: During the initial implant attempt
Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system.
During the initial implant attempt
Duration of implant procedure
Time Frame: Treatment Visit
Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.
Treatment Visit
Number of blood transfusions
Time Frame: Treatment Visit through Discharge Visit
Number of transfusions (units) required from the time of implant through hospital discharge.
Treatment Visit through Discharge Visit
Duration of hospitalization
Time Frame: Treatment Visit through Discharge Visit
Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.
Treatment Visit through Discharge Visit
Time in Intensive Care Unit (ICU)
Time Frame: Treatment Visit through Discharge Visit
Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.
Treatment Visit through Discharge Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bolton Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wilson Szeto, MD, Penn Presbyterian
  • Principal Investigator: Venkatesh Ramaiah, MD, Arizona Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IP-0015-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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