Overview

This trial is active, not recruiting.

Conditions aortic aneurysm, abdominal, aorto iliac aneurysm
Treatment fortevo endograft
Sponsor Aptus Endosystems
Start date August 2010
End date April 2015
Trial size 100 participants
Trial identifier NCT01276249, CD03335-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Technical Success
time frame: Within 24 hours of the Index procedure
Major Adverse Events (MAE)
time frame: Within 1-Month of Implantation

Secondary Outcomes

Measure
Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
time frame: 1-Month, 6-Months and 12-Months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title The STAPLE-International Post-Market Registry
Principal investigator Jean-Paul de Vries, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Aptus Endosystems.