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

  • STATUS
    Recruiting
  • End date
    Jun 26, 2024
  • participants needed
    110
  • sponsor
    Bolton Medical
Updated on 26 January 2021
Investigator
Valerie DePetrillo
Primary Contact
Jichi Medical University Saitama Medical Center (6.3 mi away) Contact
+48 other location

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.

Description

The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

Details
Condition Thoracic aortic aneurysm, Penetrating Ulcer
Treatment RelayPro
Clinical Study IdentifierNCT02818972
SponsorBolton Medical
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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