A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Status: Active, not recruiting
Location: See all (37) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Alabama
University of Alabama-Birmingham
Birmingham
Arizona
Arizona Heart Institute
Phoenix
California
University of California, Irvine
Irvine
Long Beach Memorial Hospital
Long Beach
Connecticut
Hartford Hospital
Hartford
Florida
University of Florida
Gainesville
Georgia
Emory University
Atlanta
Iowa
University of Iowa Hospital and Clinic
Iowa City
Indiana
Indiana University Health
Indianapolis
St. Vincent Heart Center
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston
Tufts Medical Center
Boston
Baystate Medical Center
Springfield
Michigan
University of Michigan
Ann Arbor
North Carolina
East Carolina University Brody School of Medicine
Greenville
New Jersey
Newark Beth Israel Medical Center
Newark
New York
New York University
New York
Ohio
Cleveland Clinic Foundation
Cleveland
University Hospitals
Cleveland
Pennsylvania
University of Pennsylvania Medical Center / Penn Presbyterian
Philadelphia
Lankenau Medical Center
Wynnewood
Tennessee
Centennial Heart & Vascular Institute Sarah Cannon Research Institute
Nashville
Vanderbilt University Medical Center
Nashville
Texas
University of Texas Southwestern
Dallas
Baylor Scott & White Medical Center - Plano The Heart Hospital
Plano
Baylor Scot & White Medical Center - Temple
Temple
Other Locations
Japan
Hiroshima University Hospital
Hiroshima
Morinomiya Hospital
Joto-ku
Nara Medical University Hospital
Kashihara
Jikei University Hospital
Minato-ku
Nagoya University Hospital
Nagoya
Niigata University Medical & Dental Hospital
Niigata City
Jichi Medical University Saitama Medical Center
Ōmiya
Teine Keihinkai Hospital
Sapporo
Keio University Hospital
Shinjuku-ku
National Cerebral & Cardiovascular Center
Suita
Oita University Hospital
Yufu City
Time Frame
Start Date: May 10, 2017
Estimated Completion Date: June 2024
Participants
Target number of participants: 110
Treatments
Experimental: RelayPro
Endovascular treatment with the investigational device.
Related Therapeutic Areas
Sponsors
Leads: Bolton Medical

This content was sourced from clinicaltrials.gov

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