The STAPLE International Post-Market Registry

Covidien

Status: Terminated

Conditions: Aorto Iliac Aneurysm; Aortic Aneurysm, Abdominal

Treatments: Device: Fortevo Endograft

Study type: Observational

Funder types: Industry

Identifiers

NCT01276249

CD03335-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

108 participants in 1 patient group

Fortevo Endograft

Description:

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.

Treatment:

Device: Fortevo Endograft