Active, not recruitingNo phase
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Key facts
- Who runs it
- Bolton Medical
- Where
- Ann Arbor, Atlanta, Birmingham, Boston, Cleveland, Dallas, Gainesville, Hartford, Indianapolis, Iowa City, Irvine, Long Beach, Nashville, Newark, Philadelphia, Phoenix, Plano, Springfield, Temple, and Wynnewood, United StatesSee the 24 sitesAlso in 1 other country, 11 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 110 people, planned
- Started
- 10 May 2017
- Ended
- Dec 2025
- Type of study
- Interventional
- Treatments tested
- RelayPro
- Record updated
- 31 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 take part
- Subjects with specified prior procedures
- 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
- 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
- Subject anatomy with significant stenosis, calcification, thrombus or tortuosity
- Subjects with specified compromised circulation
- Subjects that are pregnant or planning to become pregnant during the course of the study
Where in United States
Also in 1 other country, 11 sites
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Emory UniversityAtlanta, United StatesNo longer taking part
- University of Alabama BirminghamBirmingham, United StatesNo longer taking part
- Beth Israel Deaconess Medical Center, Harvard Medical SchoolBoston, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- University HospitalsCleveland, United StatesNo longer taking part
- University of Texas, SouthwesternDallas, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Hartford HospitalHartford, United StatesNo longer taking part
- Indiana University HealthIndianapolis, United StatesNo longer taking part
- St. Vincent Heart CenterIndianapolis, United StatesNo longer taking part
- University of Iowa Hospital and ClinicIowa City, United StatesNo longer taking part
- University of California, IrvineIrvine, United StatesNo longer taking part
- Long Beach Memorial HospitalLong Beach, United StatesNo longer taking part
- Centennial Heart & Vascular Institute Sarah Cannon Research InstituteNashville, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Newark Beth Israel Medical CenterNewark, United StatesNo longer taking part
- University of Pennsylvania Medical Center / Penn PresbyterianPhiladelphia, United StatesNo longer taking part
- Arizona Heart InstitutePhoenix, United StatesNo longer taking part
- Baylor Scott & White Medical Center - Plano The Heart HospitalPlano, United StatesNo longer taking part
- Baystate Medical CenterSpringfield, United StatesNo longer taking part
- Baylor Scot & White Medical Center - TempleTemple, United StatesNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- RelayProTreatment being tested
Endovascular treatment with the investigational device.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 31 May 2025