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

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: Active, not recruiting
• Conditions: Aortic Aneurysm, Thoracic; Penetrating Ulcer
• Intervention / Treatment: Device: RelayPro

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: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

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
  • New York
    • New York, New York, United States, 10016
      • New York University
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University Brody School of Medicine
  • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RelayPro; Endovascular treatment with the investigational device.	Device: RelayPro; Endovascular treatment with investigational device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days
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.	24 hours
Stent graft patency	Primary effectiveness as measured by the rate of stent-graft patency through 12 months.	12 months
Aneurysm rupture	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;	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	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	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)	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	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

Outcome Measure	Measure Description	Time Frame
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.	1 month and 6 months
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.	1 month and 6 months
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.	1 month, 6 months and 12 months
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.	1 month and 6 months
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).	1 month and 6 months
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	1 month and 6 months
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.	1 month and 6 months
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.	6 months and 12 months
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.	During the initial implant attempt
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.	Treatment Visit
Number of blood transfusions	Number of transfusions (units) required from the time of implant through hospital discharge.	Treatment Visit through Discharge Visit
Duration of hospitalization	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)	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

• Sponsor: Bolton Medical
• Investigators: Principal Investigator: Wilson Szeto, MD, Penn Presbyterian; Principal Investigator: Venkatesh Ramaiah, MD, Arizona Heart Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): June 24, 2022
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimated): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Diseases; Acute Aortic Syndrome; Ulcer; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Penetrating Atherosclerotic Ulcer
• Other Study ID 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