Endurant Evo US Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Medtronic Cardiovascular
- Enrollment
- 139
- Locations
- 14
- Primary Endpoint
- The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Detailed Description
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥18 years old
- •Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
- •Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
- •Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
- •Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
- •Aneurysm is \>5 cm in diameter (diameter measured is perpendicular to the line of flow)
- •Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months
- •Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced computed tomography (CTA) or magnetic resonance angiography (MRA) imaging:
- •Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation
- •Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU))
Exclusion Criteria
- •Subject has a life expectancy ≤1 year
- •Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
- •Subject is pregnant
- •Subject has an aneurysm that is:
- •Suprarenal/pararenal/juxtarenal
- •Isolated ilio-femoral
- •Inflammatory
- •Pseudoaneurysm
- •Dissecting
- •Leaking but not ruptured
Outcomes
Primary Outcomes
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
Time Frame: 30-days
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Time Frame: 12-months
Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco
Secondary Outcomes
- Aneurysm Rupture(within 183 and 365 days)
- All Endoleaks Based on Imaging Findings(at 1-, 6-, and 12-month follow-up visits)
- All-cause Mortality(within 30, 183, and 365 days)
- Secondary Procedures to Correct Type I and III Endoleaks(within 183, and 365 days)
- Serious Adverse Events(within 30, 183, and 365 days)
- Stent Graft Migration(At 6- and 12-month follow-up visits (as compared to 1-month imaging))
- Aneurysm-related Mortality (ARM)(within 30, 183, and 365 days)
- Conversion to Open Surgery(within 183, and 365 days)
- Aneurysm Expansion >5 mm(at 6- and 12-month follow-up visits (as compared to 1-month imaging))
- Device Deficiencies Based on Imaging Findings(Through 6- and 12 months)
- Secondary Procedures(within 183, and 365 days)
- Major Adverse Events(within 183 and 365 days)
- Stent Graft Occlusions Based on Imaging Findings(Through 1-, 6- and 12 months)