NCT01991756

Safety and Performance of Altura Endograft in Abdominal Aortic Aneurysm (AAA) Endovascular Repair

ELEVATE International: Kissing Endografts for Peripheral AAA Exclusion

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Altura Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair. Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.

Detailed description

The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.

Conditions

• Abdominal Aortic Aneurysms

Interventions

Type	Name	Description
DEVICE	Altura Endograft System	Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.

Timeline

• Start date: 2014-04-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2013-11-25
• Last updated: 2015-01-15

Locations

4 sites across 1 country: Germany