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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01991756
Study type Observational
Source Altura Medical Inc.
Contact
Status Enrolling by invitation
Phase N/A
Start date April 2014
Completion date March 2020

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