Clinical trial NCT01276249: The STAPLE International Post-Market Registry
Official title: The STAPLE-International Post-Market Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Aneurysm, Abdominal
Aorto Iliac Aneurysm
Keywords: Aptus Endosystem
EndoStaple
Endograft
Stent Graft
Abdominal Aortic Aneurysm
Heli-FX
EndoAnchor
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair.

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

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 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)

Primary outcomes:
measure: Technical Success
timeFrame: Within 24 hours of the Index procedure
measure: Major Adverse Events (MAE)
timeFrame: Within 1-Month of Implantation
Secondary outcomes:
measure: Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components
timeFrame: 1-Month, 6-Months and 12-Months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Sherbrooke University Hospital Centre
state: Quebec
city: Berlin
country: Germany
facility: German Heart Center
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt
city: Lingen
country: Germany
facility: St. Bonifatious Hospital
city: Athens
country: Greece
facility: Hellenic Airforce Hospital
city: Siena
country: Italy
facility: University of Siena
city: Nieuwegein
country: Netherlands
facility: St Antonious Hospital
city: Barcelona
country: Spain
facility: Thorax Institute Hospital Clinic
city: Pamplona
country: Spain
facility: University of Navarra
Study officials:
affiliation: St Antonius Hospital - Nieuwegein, Netherlands
name: Jean-Paul de Vries, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.