TREO PAS-IP-0021-20
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StatusAccepting Candidates
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Age18 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
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
Full study title | Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients with Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms |
Protocol number | OCR40353 |
ClinicalTrials.gov ID | NCT04697784 |
Phase | N/A |
Eligibility
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.
Lead researcher
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Michol A Cooper, MD, PhDVascular Surgeon
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Michol Cooper -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.