Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
108 participants
OBSERVATIONAL
2010-08-31
2015-06-19
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Paul de Vries, MD
Role: PRINCIPAL_INVESTIGATOR
St Antonius Hospital - Nieuwegein, Netherlands
Locations
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Sherbrooke University Hospital Centre
Sherbrooke, Quebec, Canada
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
Thorax Institute Hospital Clinic
Barcelona, , Spain
University of Navarra
Pamplona, , Spain
Countries
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References
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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.
Other Identifiers
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CD03335-01
Identifier Type: -
Identifier Source: org_study_id