Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    TREO | Recruiting, Not yet recruiting Studies
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697784
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

Brief 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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: TREO Abdominal Stent-Graft System Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Abdominal Aortic Aneurysm Stent-Graft
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subjects who receive the TREO Abdominal Stent-Graft System
Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.
Device: TREO Abdominal Stent-Graft System
The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.




Primary Outcome Measures :
  1. Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory. [ Time Frame: Through 5 Years post-procedure ]
    Incidence of fracture in a stent-strut or separation of one or more proximal fixation barbs as confirmed by the Imaging Core Laboratory upon review of post-implant imaging studies.

  2. Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation. [ Time Frame: Through 5 Years post-procedure ]
    Incidence of secondary intervention for adverse events related to or caused as a result of a fracture in a stent-strut or separation of one or more proximal fixation barbs. Relatedness to the device will be confirmed by the Clinical Events Committee (CEC) through review of available treatment and procedure records and reports of imaging studies.


Secondary Outcome Measures :
  1. Number of participants with technical success at the conclusion of the index procedure [ Time Frame: Through 5 Years post-procedure ]

    Defined as the following:

    • successful delivery (i.e., ability to deliver the implant to the intended location without the need for unanticipated corrective intervention related to delivery);
    • successful and accurate deployment (deployment of the endovascular stent graft in the planned location; patency of the endovascular stent graft, absence of device deformations such as kinks, stent eversion, mal-deployment, misaligned deployment, requiring unplanned placement of an additional device within the endovascular stent graft, and
    • successful withdrawal (i.e. successful withdrawal of the delivery system, without the need for unanticipated corrective intervention related to withdrawal)

  2. Major Adverse Events [ Time Frame: Through 5 Years post-procedure ]

    Incidence of the following Major Adverse Events

    • Myocardial infarction according to SCAI definition
    • Stroke according to the VARC-2 guidelines
    • New Onset Renal Failure requiring permanent dialysis
    • New onset Respiratory Failure requiring permanent home oxygen therapy through 30 days
    • Permanent Paralysis/Paraplegia
    • Bowel Ischemia
    • Procedural blood loss (≥ 1000cc)

  3. Incidence of procedure-related clinical utility measures [ Time Frame: Through 5 Years post-procedure ]
    Reporting of procedural data collected during implant of the TREO Abdominal Stent-Graft System including: Procedure time (minutes), Fluoroscopy time (minutes), Contrast volume (mL), Access method (i.e. percutaneous, surgical cut down), Length of ICU stay (hours), Length of hospital stay post-procedure (days), Anesthesia Type.

  4. Incidence of procedure-related complications [ Time Frame: Through 5 Years post-procedure ]
    Incidence of adverse events occurring during or following the implant determined by the CEC to be procedure-related.

  5. Incidence of successful aneurysm treatment [ Time Frame: 12 months post-implant ]

    Successful aneurysm treatment is defined as:

    • Technical success
    • Absence of death from the initial procedure, secondary intervention or aortic-related cause.
    • Absence of persistent type I or III endoleaks
    • Absence of aneurysm sac expansion >5 mm
    • Absence of device migration >10mm
    • Absence of failure due to device integrity issues
    • Absence of aneurysm rupture
    • Absence of conversion to open surgical repair
    • Absence of permanent paraplegia, disabling stroke or dialysis that resulted from the initial operation or a secondary intervention to treat the original aortic pathology.

  6. Incidence of all-cause mortality [ Time Frame: Through 5 Years post-procedure ]
    Rate of mortality attributed to any causality as confirmed by the CEC.

  7. Incidence of aneurysm-related mortality [ Time Frame: Through 5 Years post-procedure ]
    Rate of mortality attributed to the following causes as confirmed by the CEC: death due to a rupture, death within 30 days or prior to hospital discharge from primary procedure, or death within 30 days or prior to hospital discharge for a secondary procedure designed to treat the original aneurysm.

  8. Incidence of aneurysm rupture [ Time Frame: Through 5 Years post-procedure ]
    Incidence of rupture of the native aneurysm sac post-implantation of the endograft as confirmed by the CEC.

  9. Incidence of secondary interventions. [ Time Frame: Through 5 Years post-procedure ]
    Incidence of secondary procedures designed to treat or repair the original aneurysm treated with the TREO Abdominal Stent-Graft System

  10. Incidence of conversion to open surgical repair. [ Time Frame: Through 5 Years post-procedure ]
    Incidence of conversion to open surgical AAA repair during the initial EVAR procedure secondary to any procedure-related complications as determined by the CEC.

  11. Incidence of stent-graft occlusion (i.e., loss of patency) [ Time Frame: Through 5 Years post-procedure ]
    Incidence of stent-graft occlusion defined as the unintentional obstruction of the vascular/endograft lumen with minor obstruction (0-25%), minimal obstruction (26-74%), moderate obstruction (75-99%) or occlusion (100%) as confirmed by the Imaging Core Lab due to causes such as twisting or kinking of the prosthesis, oversizing and fabric pleating, or failure of the implant to fully open, or to mural thrombus deposition.

  12. Incidence of device stenosis or kink [ Time Frame: Through 5 Years post-procedure ]
    Incidence of stenosis or kinking of the TREO Stent-Graft as confirmed by the Imaging Core Lab.

  13. Incidence of loss of device integrity [ Time Frame: Through 5 Years post-procedure ]
    Incidence of changes in the structural integrity in a material component of the stent-graft such as a stent-strut fracture or separation of the proximal fixation barbs as confirmed by the Imaging Core Lab.

  14. Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging). [ Time Frame: Through 5 Years post-procedure ]
    Incidence of the increase in the aneurysm sac diameter > 5 mm at post-implant follow-up visits relative to the diameter determined at the first post-procedural imaging study, as confirmed by the Imaging Core Lab.

  15. Incidence of stent-graft migration (>10mm as compared to 30-day imaging) [ Time Frame: Through 5 Years post-procedure ]
    Incidence of the longitudinal movement of all or part of a stent or attachment system for a distance of >10 mm relative to anatomical landmarks that were determined at the first post-procedural imaging study as confirmed by the Imaging Core Lab.

  16. Incidence of Type I, II, III, IV or V Endoleaks [ Time Frame: Through 5 Years post-procedure ]
    Incidence of Type I, II, III, IV or V Endoleaks defined as the persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft as determined by the Imaging Core Lab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697784


Contacts
Layout table for location contacts
Contact: Gretchen Wild 954-779-6393 g.wild@terumoaortic.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
Bolton Medical
Layout table for additonal information
Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT04697784    
Other Study ID Numbers: IP-0021-20
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bolton Medical:
AAA
Abdominal Aortic Aneurysm
TREO
EVAR
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases