Post-Approval Study of the TREO Abdominal Stent-Graft System (TREO PAS)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2027
  • participants needed
    300
  • sponsor
    Bolton Medical
Updated on 24 May 2022

Summary

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

Description

This is a prospective, multi-center, non-randomized, single-arm, post-market, non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms. The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US.

The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.

Details
Condition Abdominal Aortic Aneurysm
Treatment TREO Abdominal Stent-Graft System
Clinical Study IdentifierNCT04697784
SponsorBolton Medical
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to comply with all study procedures and visits
Written informed consent to participate in the study
Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System
Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively

Exclusion Criteria

• Medical, social or psychological problems that, in the opinion of the investigator
preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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