Clinical Trials Logo
  1. Home
  2. Abdominal Aortic Aneurysm
  3. NCT05143138

Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries — EMBRACE  

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries

Clinical Trial Summary

Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.

Clinical Trial Description

Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries. The registry procedures consist of two phases, retrospective phase and prospective phase. The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature). The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05143138
Study type Observational [Patient Registry]
Source W.L.Gore & Associates
Contact
Status Active, not recruiting
Phase
Start date March 23, 2022
Completion date July 2026
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04227054 - Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks N/A
Active, not recruiting NCT03687489 - Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System N/A
Active, not recruiting NCT03507413 - Metformin Therapy in Non-diabetic AAA Patients Phase 2/Phase 3
Not yet recruiting NCT05756283 - The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair N/A
Not yet recruiting NCT04089241 - Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair N/A
Active, not recruiting NCT02604303 - A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms
Terminated NCT01843335 - Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair N/A
Completed NCT02229006 - Sodium Fluoride Imaging of Abdominal Aortic Aneurysms N/A
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Completed NCT02224794 - LIFE Study: Least Invasive Fast-Track EVAR
Terminated NCT01425242 - Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension N/A
Completed NCT01118520 - AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) Phase 2
Completed NCT00746122 - Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair N/A
Completed NCT03952780 - Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)
Completed NCT00583414 - Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients N/A
Recruiting NCT05864560 - Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up
Completed NCT01683084 - Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms Phase 4
Active, not recruiting NCT03180996 - Global Fenestrated Anaconda Clinical sTudy
Completed NCT02493296 - The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study
Completed NCT03320408 - Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers