Active — Not RecruitingNot Applicable

Post-Approval Study of the TREO Abdominal Stent-Graft System

United States338 participantsStarted 2021-01-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.

Timeframe: Through 5 Years post-procedure

Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.

Timeframe: Through 5 Years post-procedure

Trial details

NCT IDNCT04697784

SponsorBolton Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07-31

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials