Clinical Trials Logo

Clinical Trial Summary

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).


Clinical Trial Description

This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted. The primary goal of this study is to gather safety and effectiveness data on the Treovance device. A maximum of 150 endovascular subjects will be required to fulfill the U.S. Phase II requirements. The data from this study will be submitted to the FDA and used to support approval in the U.S. There are two primary objectives, efficacy and safety of the Treovance Stent-Graft in subjects with infrarenal aortic aneurysms: - Primary Efficacy will be evaluated by successful aneurysm treatment 12 months post-implant - Primary Safety will be assessed by composite major adverse event (MAE) rate at 30-days Secondary objectives involve assessment of major device-related events and major morbidity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02009644
Study type Interventional
Source Bolton Medical
Contact
Status Active, not recruiting
Phase N/A
Start date November 23, 2013
Completion date June 2025

See also
  Status Clinical Trial Phase
Completed NCT01480206 - Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR
Active, not recruiting NCT03743142 - Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms
Terminated NCT04592991 - CCR2 AAA Pilot Study Early Phase 1
Completed NCT01990950 - Fenestrated AAA Endovascular Graft Post-Approval Study N/A
Withdrawn NCT04551183 - Comparative Study of a Software With the Gold Standard N/A
Completed NCT02306304 - Ultra-sound for AAA Screening in Smoking Israeli Arab Men N/A
Recruiting NCT02295137 - Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair Phase 1
Recruiting NCT04586452 - NIH CCR2 AAA Study Early Phase 1
Completed NCT01726257 - Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System N/A
Terminated NCT02007252 - ACZ885 for the Treatment of Abdominal Aortic Aneurysm Phase 2
Completed NCT02934087 - Endovascular Aneurysm Repair (EVAR) Gate Study N/A
Terminated NCT03231397 - Predictors of AAA Expansion and/or Rupture Phase 4
Completed NCT04333641 - Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography