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The STAPLE International Post-Market Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Aptus Endosystems
Sponsor:
Information provided by (Responsible Party):
Aptus Endosystems
ClinicalTrials.gov Identifier:
NCT01276249
First received: January 11, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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
Estimated Primary Completion Date: March 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.

Criteria

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 ClinicalTrials.gov identifier: NCT01276249

Contacts
Contact: Irene Kuhn 212.266.0126 ikuhn@syntactx.com
Contact: Burt Goodson 408.716.7394 bgoodson@aptusendo.com

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

Additional Information:
Publications:
Responsible Party: Aptus Endosystems
ClinicalTrials.gov Identifier: NCT01276249     History of Changes
Other Study ID Numbers: CD03335-01
Study First Received: January 11, 2011
Last Updated: November 17, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Aptus Endosystems:
Aptus Endosystem
EndoStaple
Endograft
Stent Graft
Abdominal Aortic Aneurysm
Heli-FX
EndoAnchor

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014