CTAG Dissection/Trauma Post Marketing Surveillance Japan

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-05

Study Completion Date

2022-12-23

Brief Summary

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Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis

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Detailed Description

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Conditions

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Thoracic Aortic Aneurysm Thoracic Aorta Injury Thoracic Aortic Dissection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Conformable GORE® TAG® Thoracic Endoprosthesis

Thoracic Endoprosthesis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient present with acute complicated type B aortic dissection
* Patient who do not respond to medical therapy
* Time from symptom onset to dissection diagnosis ≤ 14 days
* Adequate iliac / femoral access or conduit
* Aortic inner diameter at proximal extent of proximal landing zone in the range of 16-42 mm
* ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected

* Patient has traumatic aortic transection that requires repair as determined by treating physician
* Adequate iliac / femoral access
* Aortic inner diameter in the range of 16-42 mm on the proximal and distal sides
* ≥ 20 mm non-aneurysmal aorta neck proximal and distal to the lesion

Eligible Sex

ALL

Accepts Healthy Volunteers

No