The STAPLE International Post-Market Registry

Terminated

• Conditions: Aorto Iliac Aneurysm; Aortic Aneurysm, Abdominal
• Interventions: Device: Fortevo Endograft

• Registration Number: NCT01276249
• Lead Sponsor: Medtronic Cardiovascular

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-13
• Primary Completion: 2015-04
• Study Completion: 2015-06-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fortevo Endograft	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (9)

German Heart Center; 🇩🇪 Berlin, Germany

Sherbrooke University Hospital Centre; 🇨🇦 Sherbrooke, Quebec, Canada

St. Bonifatious Hospital; 🇩🇪 Lingen, Germany

Hellenic Airforce Hospital; 🇬🇷 Athens, Greece

University of Siena; 🇮🇹 Siena, Italy

Cardiovascular Center Frankfurt; 🇩🇪 Frankfurt, Germany

University of Navarra; 🇪🇸 Pamplona, Spain

Thorax Institute Hospital Clinic; 🇪🇸 Barcelona, Spain

St Antonious Hospital; 🇳🇱 Nieuwegein, Netherlands