CTAG Dissection/Trauma Post Marketing Surveillance Japan

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Patients with acute, complicated Stanford Type B aortic dissection and patients with traumatic aortic transection treated using Gore CTAG.

About this study

Official title: Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)

Conditions

Thoracic Aortic Aneurysm, Thoracic Aorta Injury, Thoracic Aortic Dissection

Being tested

Conformable GORE® TAG® Thoracic Endoprosthesis

Medical subject headings

Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Conformable GORE® TAG® Thoracic EndoprosthesisDevice

  Thoracic Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Primary Entry Tear Exclusion

   Number of subjects who achieved the primary entry tear exclusion

   Measured: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)

2. Aortic Rupture

   Number of subjects with Aortic Rupture

   Measured: Procedure through 5 years (Day 0-2006)

3. Major Device-related Adverse Events

   Number of subjects with major device-related adverse events

   Measured: Procedure through 5 years (Day 0-2006)

4. Secondary Intervention Treatment

   Incidence rate of secondary intervention treatment

   Measured: Post-procedure through 5 years (Day 1-2006)

5. Change in Minimum True Lumen Diameter Adjacent to Treated Segment

   Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit:

   Decrease (>=5mm) vs No change vs Increase (>=5mm)

   Measured: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)

6. Change in Minimum True Lumen Diameter Distal to Treated Segment

   Change in minimum true lumen diameter distal to treated segment at each follow-up visit:

   Decrease (>=5mm) vs No change vs Increase (>=5mm)

   Measured: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)

7. Change in Maximum False Lumen Diameter Adjacent to Treated Segment

   Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit:

   Decrease (>=5mm) vs No change vs Increase (>=5mm)

   Measured: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)

8. Change in Maximum False Lumen Diameter Distal to Treated Segment

   Change in maximum false lumen diameter distal to treated segment at each follow-up visit:

   Decrease (>=5mm) vs No change vs Increase (>=5mm)

   Measured: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)

9. Change in Maximum Lesion Diameter

   Change in maximum lesion diameter at each follow-up visit:

   Decrease (>=5mm) vs No change vs Increase (>=5mm)

   Measured: At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Jun 2022
2. Study start5 Jan 2016
3. Primary completion23 Dec 2022
4. Study completion23 Dec 2022

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
• More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.