RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
NCT ID: NCT02818972
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
110 participants
INTERVENTIONAL
2017-05-10
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RelayPro
Endovascular treatment with the investigational device.
RelayPro
Endovascular treatment with investigational device.
Interventions
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RelayPro
Endovascular treatment with investigational device.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Bolton Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Wilson Szeto, MD
Role: PRINCIPAL_INVESTIGATOR
Penn Presbyterian
Venkatesh Ramaiah, MD
Role: PRINCIPAL_INVESTIGATOR
Arizona Heart Institute
Locations
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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
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Teine Keihinkai Hospital
Sapporo, Hokkaido, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Oita University Hospital
Yufu, Oita Prefecture, Japan
Morinomiya Hospital
Joto-ku, Osaka, Japan
National Cerebral & Cardiovascular Center
Suita, Osaka, Japan
Jichi Medical University Saitama Medical Center
Ōmiya, Saitama, Japan
Jikei University Hospital
Minato-Ku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Countries
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References
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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.
Other Identifiers
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IP-0015-16
Identifier Type: -
Identifier Source: org_study_id
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