The STAPLE International Post-Market Registry

Sponsor

Medtronic Cardiovascular (Industry)

Overall Status

Terminated

CT.gov ID

NCT01276249

Collaborator

(none)

108

Enrollment

Locations

58.6

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal Aorto Iliac Aneurysm	Device: Fortevo Endograft

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 Design

Study Type:

Observational

Actual Enrollment :

108 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The STAPLE-International Post-Market Registry

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Jun 19, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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.

Arm

Intervention/Treatment

Fortevo Endograft

Device: 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.

Outcome Measures

Primary Outcome Measures

Technical Success [Within 24 hours of the Index procedure]
The first primary endpoint is primary technical success. It consists of the following items: Successful arterial access Successful deployment of the Fortevo Endograft with secure proximal and distal fixation Absence of type I or III endoleaks Patent Fortevo Endograft without significant twist, kinking, or obstruction
Major Adverse Events (MAE) [Within 1-Month of Implantation]
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: Death Myocardial Infarction Stroke (excludes TIA) Renal failure (excludes renal insufficiency) Respiratory Failure (excludes COPD or pulmonary complications) Paralysis (excludes paraparesis)

Secondary Outcome Measures

Clinical Success and Safety of the Fortevo Endograft and Heli-FX EndoAnchor System components [1-Month, 6-Months and 12-Months]
Clinical Success is defined as Successful Deployment of the Fortevo Endograft at the intended location and the absence of: Death as a result of aneurysm-related treatment Type I or III endoleak Fortevo Endograft infection Fortevo Endograft thrombosis Fortevo Endograft dilatation by 20% or more in diameter Fortevo Endograft migration by 10mm or more at the proximal neck at 6-M and 12-M Loss of Fortevo Endograft or Heli-FX EndoAnchor System integrity Aneurysm expansion by 5mm (or more) in maximal diameter at 6-M and 12-M Aneurysm rupture Conversion to open repair

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherbrooke University Hospital Centre	Sherbrooke	Quebec	Canada	J1H5N4
2	German Heart Center	Berlin		Germany
3	Cardiovascular Center Frankfurt	Frankfurt		Germany
4	St. Bonifatious Hospital	Lingen		Germany
5	Hellenic Airforce Hospital	Athens		Greece
6	University of Siena	Siena		Italy
7	St Antonious Hospital	Nieuwegein		Netherlands	3430
8	Thorax Institute Hospital Clinic	Barcelona		Spain
9	University of Navarra	Pamplona		Spain