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The STAPLE International Post-Market Registry

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Aptus Endosystems Identifier:
First received: January 11, 2011
Last updated: July 14, 2015
Last verified: July 2015
The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

Condition Intervention
Aortic Aneurysm, Abdominal
Aorto Iliac Aneurysm
Device: Fortevo Endograft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The STAPLE-International Post-Market Registry

Resource links provided by NLM:

Further study details as provided by Aptus Endosystems:

Primary Outcome Measures:
  • 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)

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

    Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of:

    • Death as a result of aneurysm-related treatment
    • Type I or III endoleak
    • Fortevo Endograft infection
    • Fortevo Endograft thrombosis
    • Fortevo Endograft dilatation by 20% or more in diameter
    • Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M
    • Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity
    • Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M
    • Aneurysm rupture
    • Conversion to open repair

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: March 2018
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fortevo Endograft
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 if treated with the Fortevo Endograft.
Device: Fortevo Endograft
The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.

Inclusion Criteria:

  1. Patient ≥ 18 years old
  2. Patient has given written informed consent
  3. Patient has a life expectancy > 1 year
  4. Patient is willing to comply with follow-up evaluations
  5. Patient's AAA meets at least one of the following criteria:

    • ≥ 4.5cm in diameter
    • Increased in size by 0.5cm in last 6 months
    • Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment
    • Saccular aneurysm larger than 3cm in maximal diameter
  6. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
  7. Patient has a proximal aortic neck length of at least 12mm
  8. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.
  9. Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm

Exclusion Criteria:

  1. Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
  2. Patient has a symptomatic AAA
  3. Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm
  4. Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
  5. Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
  6. Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
  7. Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)
  8. Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01276249

Canada, Quebec
Sherbrooke University Hospital Centre
Sherbrooke, Quebec, Canada, J1H5N4
German Heart Center
Berlin, Germany
Cardiovascular Center Frankfurt
Frankfurt, Germany
St. Bonifatious Hospital
Lingen, Germany
Hellenic Airforce Hospital
Athens, Greece
University of Siena
Siena, Italy
St Antonious Hospital
Nieuwegein, Netherlands, 3430
Thorax Institute Hospital Clinic
Barcelona, Spain
University of Navarra
Pamplona, Spain
Sponsors and Collaborators
Aptus Endosystems
Principal Investigator: Jean-Paul de Vries, MD St Antonius Hospital - Nieuwegein, Netherlands
  More Information

Responsible Party: Aptus Endosystems Identifier: NCT01276249     History of Changes
Other Study ID Numbers: CD03335-01
Study First Received: January 11, 2011
Last Updated: July 14, 2015

Keywords provided by Aptus Endosystems:
Aptus Endosystem
Stent Graft
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on May 25, 2017