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

NCT02818972 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IP-0015-16
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 35

Brief 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.

Conditions

Aortic Aneurysm, Thoracic; Penetrating Ulcer

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (13)

• Loss of stent-graft patency

  1 month and 6 months

• Rate of aneurysm rupture

  1 month and 6 months

• Rate of endoleaks of all types

  1 month, 6 months and 12 months

• Rate of stent fractures in the attachment zone

  1 month and 6 months

• Incidence of open or endovascular secondary interventions

  1 month and 6 months

Study Arms (1)

RelayPro

EXPERIMENTAL

Endovascular treatment with the investigational device.

Device: RelayPro

Interventions

RelayPro DEVICE

Endovascular treatment with investigational device.

RelayPro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bolton Medical: lead

Study Sites (35)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

University of California, Irvine

Irvine, California, 92868, United States

Location

Long Beach Memorial Hospital

Long Beach, California, 90806, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospital and Clinic

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center / Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Medical Center / Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Centennial Heart & Vascular Institute Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Baylor Scott & White Medical Center - Plano The Heart Hospital

Plano, Texas, 75093, United States

Location

Baylor Scot & White Medical Center - Temple

Temple, Texas, 76508, United States

Location

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Location

Teine Keihinkai Hospital

Sapporo, Hokkaido, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, Japan

Location

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan

Location

Oita University Hospital

Yufu, Oita Prefecture, Japan

Location

Morinomiya Hospital

Joto-ku, Osaka, Japan

Location

National Cerebral & Cardiovascular Center

Suita, Osaka, Japan

Location

Jichi Medical University Saitama Medical Center

Ōmiya, Saitama, Japan

Location

Jikei University Hospital

Minato-Ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 35241276 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Penetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Wilson Szeto, MD

  Penn Presbyterian

  PRINCIPAL INVESTIGATOR

• Venkatesh Ramaiah, MD

  Arizona Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 30, 2016
• Study Start: May 10, 2017
• Primary Completion: June 24, 2022
• Study Completion: December 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (11); US (24)