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

Running, not enrolling · Not applicable

Conditions studied: Aortic Aneurysm, Thoracic, Penetrating Ulcer

In brief

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.

Key facts

Study ID

NCT02818972

Run by

Bolton Medical

People needed

110

Starts

2017-05-10

Expected to finish

2025-12-01

Last updated by the study team

2025-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama-Birmingham — Birmingham, Alabama, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• Long Beach Memorial Hospital — Long Beach, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University Health — Indianapolis, Indiana, United States
• St. Vincent Heart Center — Indianapolis, Indiana, United States
• University of Iowa Hospital and Clinic — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center / Harvard Medical School — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• University Hospitals — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Medical Center / Penn Presbyterian — Philadelphia, Pennsylvania, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Centennial Heart & Vascular Institute Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Baylor Scott & White Medical Center - Plano The Heart Hospital — Plano, Texas, United States
• Baylor Scot & White Medical Center - Temple — Temple, Texas, United States
• Nagoya University Hospital — Nagoya, Aichi-ken, Japan

Full record on ClinicalTrials.gov

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