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Clinical Trials/ISRCTN13771116
ISRCTN13771116
Active, not recruiting
未知

Multi-centre observational post-market real world registry

ombard Medical0 sites1,200 target enrollmentMarch 6, 2017
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ConditionsAbdominal aortic aneurysmsCirculatory System

Overview

Phase
未知
Intervention
Not specified
Conditions
Abdominal aortic aneurysms
Sponsor
ombard Medical
Enrollment
1200
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 6, 2017
End Date
September 30, 2024
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ombard Medical

Eligibility Criteria

Inclusion Criteria

  • •1\. Patient being implanted with an Altura stent graft
  • •2\. Male or female at least 60 years’ old
  • •3\. Subject has signed informed consent for data and image release
  • •4\. Subjects with abdominal aortic aneurysm and eligible for endovascular repair

Exclusion Criteria

  • •1\. Currently participating in another related study where primary endpoint has not been reached yet
  • •2\. Mycotic or infected aneurysms
  • •3\. Aneurysms associated with a known connective tissue disorder
  • •4\. Occluded iliac access vessels
  • •5\. Ruptured abdominal aortic aneurysm
  • •6\. Patients deemed by the investigator to lie outside the Instructions for Use of the Altura®\-System
  • •7\. Life expectancy less than 2 years
  • •8\. Known allergy to any of the device components
  • •9\. Pregnancy or breastfeeding or any plan to become pregnant during the study

Outcomes

Primary Outcomes

Not specified

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