NCT01276249

The STAPLE International Post-Market Registry

The STAPLE-International Post-Market Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Aneurysm, Abdominal
• Aorto Iliac Aneurysm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-04-01
• Completion: 2015-06-19
• First posted: 2011-01-13
• Last updated: 2021-11-02

Locations

9 sites across 6 countries: Canada, Germany, Greece, Italy, Netherlands, Spain