Clinical Trial: The STAPLE International Post-Market Registry

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: The STAPLE-International Post-Market Registry

Brief Summary: The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

Detailed Summary:

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.

Sponsor: Aptus Endosystems

Current Primary Outcome:

• Technical Success [ Time Frame: Within 24 hours of the Index procedure ]

  The first primary endpoint is primary technical success. It consists of the following items:

  • Successful arterial access
  • Successful deployment of the Fortevo Endograft with secure proximal and distal fixation
  • Absence of type I or III endoleaks
  • Patent Fortevo Endograft without significant twist, kinking, or obstruction
• Major Adverse Events (MAE) [ Time Frame: Within 1-Month of Implantation ]

  The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events:

  • Death
  • Myocardial Infarction
  • Stroke (excludes TIA)
  • Renal failure (excludes renal insufficiency)
  • Respiratory Failure (excludes COPD or pulmonary complications)
  • Paralysis (excludes paraparesis)

Original Primary Outcome:

• Technical Success [ Time Frame: Within 24 hours of the Index procedure ]

  The first primary endpoint is primary technical success. It consists of the following items:

  • Successful arterial access
  • Successful deployment of the Endograft with secure proximal and distal fixation
  • Absence of type I or III endoleaks
  • Patent Endograft without significant twist, kinking, or obstruction
• Major Adverse Events (MAE) [ Time Frame: Within 1-Month of Implantation ]

  The second primary endpoint is associated with the safety profile of the device, and is defined as the percent of patients experiencing one or more of major adverse events (MAE) within one month of implantation. MAE are defined as any one of the following events:

  • Death
  • Myocardial Infarction
  • Stroke (excludes TIA)
  • Renal failure (excludes renal insufficiency)
  • Respiratory Failure (excludes COPD or pulmonary complications)
  • Paralysis (excludes paraparesis)

Current Secondary Outcome: Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components [ Time Frame: 1-Month, 6-Months and 12-Months ]

Original Secondary Outcome: Clinical Success and Safety of the Aptus Endograft and EndoStaple components [ Time Frame: 1-Month, 6-Months and 12-Months ]

Information By: Aptus Endosystems

Dates:
Date Received: January 11, 2011
Date Started: August 2010
Date Completion: March 2018
Last Updated: July 14, 2015
Last Verified: July 2015