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Aortic Aneurysm, ThoracicRelayPro-ANCT02818972

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

A study testing RelayPro in people with Aortic Aneurysm, Thoracic and Penetrating Ulcer, run by Bolton Medical at 35 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Aneurysm, Thoracic, Penetrating Ulcer
What is being tested?
RelayPro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
35 sitesin 2 countries
Study dates
10 May 2017to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States24 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama-Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center / Harvard Medical School

    Boston, Massachusetts, 02215

  • University Hospitals

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • University of Florida

    Gainesville, Florida, 32610

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • St. Vincent Heart Center

    Indianapolis, Indiana, 46260

  • University of Iowa Hospital and Clinic

    Iowa City, Iowa, 52242

  • University of California, Irvine

    Irvine, California, 92868

  • Long Beach Memorial Hospital

    Long Beach, California, 90806

  • Centennial Heart & Vascular Institute Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • University of Pennsylvania Medical Center / Penn Presbyterian

    Philadelphia, Pennsylvania, 19104

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • Baylor Scott & White Medical Center - Plano The Heart Hospital

    Plano, Texas, 75093

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Baylor Scot & White Medical Center - Temple

    Temple, Texas, 76508

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Japan11 sites

  • Hiroshima University Hospital

    Hiroshima, Hiroshima

  • Morinomiya Hospital

    Joto-ku, Osaka

  • Nara Medical University Hospital

    Kashihara, Nara

  • Jikei University Hospital

    Minato-Ku, Tokyo

  • Nagoya University Hospital

    Nagoya, Aichi-ken

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata

  • Jichi Medical University Saitama Medical Center

    Ōmiya, Saitama

  • Teine Keihinkai Hospital

    Sapporo, Hokkaido

  • Keio University Hospital

    Shinjuku-Ku, Tokyo

  • National Cerebral & Cardiovascular Center

    Suita, Osaka

  • Oita University Hospital

    Yufu, Oita Prefecture

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
RelayPro
Medical subject headings
Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelayProDevice

    Endovascular treatment with investigational device.

Study groups in NCT02818972
Study groupRoleWhat they receive
RelayProExperimentalEndovascular treatment with the investigational device.
Receives: Device: RelayPro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Major Adverse Events (MAEs)

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

    • Death
    • Stroke (excluding transient ischemic attack)
    • Paralysis (excludes paraparesis)

    Measured: 30 days

  2. Technical success

    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.

    Measured: 24 hours

  3. Stent graft patency

    Primary effectiveness as measured by the rate of stent-graft patency through 12 months.

    Measured: 12 months

  4. Aneurysm rupture

    Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.

    Measured: 12 months

  5. Absence of Type I and III endoleak through 12 months;

    Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.

    Measured: 12 months

  6. Absence of stent fractures in the attachment zone through 12 months

    Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.

    Measured: 12 months

  7. Absence of open or endovascular secondary interventions

    Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.

    Measured: 12 months

  8. Absence of aneurysm expansion (> 5 mm diameter increase)

    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.

    Measured: 12 months

  9. Absence of stent-graft migration

    Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT.

    Measured: 12 months

Secondary outcomes (13)

  1. Loss of stent-graft patency

    Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.

    Measured: 1 month and 6 months

  2. Rate of aneurysm rupture

    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.

    Measured: 1 month and 6 months

  3. Rate of endoleaks of all types

    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.

    Measured: 1 month, 6 months and 12 months

  4. Rate of stent fractures in the attachment zone

    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.

    Measured: 1 month and 6 months

  5. Incidence of open or endovascular secondary interventions

    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).

    Measured: 1 month and 6 months

  6. Rate of aneurysm expansion

    The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT

    Measured: 1 month and 6 months

  7. Rate of stent-graft migration

    The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.

    Measured: 1 month and 6 months

  8. Individual outcomes of composite MAEs

    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.

    Measured: 6 months and 12 months

  9. Rate of vascular access complications

    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.

    Measured: During the initial implant attempt

  10. Duration of implant procedure

    Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.

    Measured: Treatment Visit

  11. Number of blood transfusions

    Number of transfusions (units) required from the time of implant through hospital discharge.

    Measured: Treatment Visit through Discharge Visit

  12. Duration of hospitalization

    Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.

    Measured: Treatment Visit through Discharge Visit

  13. Time in Intensive Care Unit (ICU)

    Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.

    Measured: Treatment Visit through Discharge Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2016 (estimated)
  2. Study start10 May 2017
  3. Primary completion24 Jun 2022
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02818972
Sponsor's protocol ID
IP-0015-16
Acronym
RelayPro-A
Status last verified
Apr 2025
First submitted
27 Jun 2016
Last updated
31 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Szeto WY, Vallabhajosyula P, Matsuda H, Moainie SL, Sharafuddin MJ, Corvera J, Smolock CJ, Miyamoto S, Naslund T, Ramaiah V; RelayPro-A Investigators. One-year results with a low-profile endograft in subjects with thoracic aortic aneurysm and ulcer pathologies. J Thorac Cardiovasc Surg. 2022 May;163(5):1739-1750.e4. doi: 10.1016/j.jtcvs.2021.10.071. Epub 2022 Feb 1.

    PubMed 35241276

Questions about this trial

What is this clinical trial studying?

A study testing RelayPro in people with Aortic Aneurysm, Thoracic and Penetrating Ulcer, run by Bolton Medical at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Major Adverse Events (MAEs) (time frame: 30 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02818972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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