- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01276249
The STAPLE International Post-Market Registry
The STAPLE-International Post-Market Registry
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H5N4
- Sherbrooke University Hospital Centre
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Berlin, Germany
- German Heart Center
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Frankfurt, Germany
- Cardiovascular Center Frankfurt
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Lingen, Germany
- St. Bonifatious Hospital
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Athens, Greece
- Hellenic Airforce Hospital
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Siena, Italy
- University of Siena
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Nieuwegein, Netherlands, 3430
- St Antonious Hospital
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Barcelona, Spain
- Thorax Institute Hospital Clinic
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Pamplona, Spain
- University of Navarra
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient ≥ 18 years old
- Patient has given written informed consent
- Patient has a life expectancy > 1 year
- Patient is willing to comply with follow-up evaluations
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
- Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
- Patient has a proximal aortic neck length of at least 12mm
- 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.
- Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm
Exclusion Criteria:
- Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
- Patient has a symptomatic AAA
- Patient's AAA has a proximal aortic neck angle that is > 60 degrees between the infrarenal neck and the long axis of the aneurysm
- Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
- Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
- Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
- 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)
- Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Technical Success
Time Frame: Within 24 hours of the Index procedure
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The first primary endpoint is primary technical success. It consists of the following items:
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Within 24 hours of the Index procedure
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Major Adverse Events (MAE)
Time Frame: Within 1-Month of Implantation
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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:
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Within 1-Month of Implantation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
Time Frame: 1-Month, 6-Months and 12-Months
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Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of:
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1-Month, 6-Months and 12-Months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Paul de Vries, MD, St Antonius Hospital - Nieuwegein, Netherlands
Publications and helpful links
General Publications
- Deaton DH. Future technologies to address the failed endoprosthesis. Semin Vasc Surg. 2009 Jun;22(2):111-8. doi: 10.1053/j.semvascsurg.2009.04.010.
- Deaton DH, Mehta M, Kasirajan K, Chaikof E, Farber M, Glickman MH, Neville RF, Fairman RM. The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year. J Vasc Surg. 2009 Apr;49(4):851-7; discussion 857-8. doi: 10.1016/j.jvs.2008.10.064.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD03335-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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