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CompletedNCT05414318Updated Oct 3, 2024Results posted

CTAG Dissection/Trauma Post Marketing Surveillance Japan

An observational study in Thoracic Aortic Aneurysm, Thoracic Aorta Injury and Thoracic Aortic Dissection, sponsored by W.L.Gore & Associates. Completed. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by W.L.Gore & Associates · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
55
Sex
All
01

Study summary

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

02

Conditions studied

  • Thoracic Aortic Aneurysm
  • Thoracic Aorta Injury
  • Thoracic Aortic Dissection
03

In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's enrollment of 55 is below the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.

Browse W.L.Gore & Associates studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria for Acute, Complicated Stanford Type B Aortic Dissection:

  • 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

Inclusion Criteria for Traumatic Aortic Transection:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Interventions

  • DeviceConformable GORE® TAG® Thoracic Endoprosthesis

    Thoracic Endoprosthesis

06

What researchers measure

Primary outcomes

  1. Primary Entry Tear Exclusion

    Number of subjects who achieved the primary entry tear exclusion

    Time frame: 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

    Time frame: Procedure through 5 years (Day 0-2006)

  3. Major Device-related Adverse Events

    Number of subjects with major device-related adverse events

    Time frame: Procedure through 5 years (Day 0-2006)

  4. Secondary Intervention Treatment

    Incidence rate of secondary intervention treatment

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

07

Results

Posted Oct 3, 2024

Participant flow

Participant flow — Overall Study
MilestoneDissectionTrauma
Started4312
Completed215
Not completed227

Outcome measures

PrimaryPrimary Entry Tear Exclusion

Number of subjects who achieved the primary entry tear exclusion

Time frame:
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)
Reported as:
Count of participants · Participants
Primary Entry Tear Exclusion
ParticipantsDissection
1 Month21
6 Months26
12 Months27
24 Months22
36 Months19
48 Months17
60 Months20
PrimaryAortic Rupture

Number of subjects with Aortic Rupture

Time frame:
Procedure through 5 years (Day 0-2006)
Reported as:
Count of participants · Participants
Aortic Rupture
ParticipantsDissection
Aortic Rupture2
PrimaryMajor Device-related Adverse Events

Number of subjects with major device-related adverse events

Time frame:
Procedure through 5 years (Day 0-2006)
Reported as:
Count of participants · Participants
Major Device-related Adverse Events
ParticipantsDissectionTrauma
Major Device-related Adverse Events30
PrimarySecondary Intervention Treatment

Incidence rate of secondary intervention treatment

Time frame:
Post-procedure through 5 years (Day 1-2006)
Reported as:
Count of participants · Participants
Secondary Intervention Treatment
ParticipantsDissectionTrauma
Secondary Intervention Treatment50
PrimaryChange 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)

Time frame:
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)
Reported as:
Count of participants · Participants
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
ParticipantsDissection
1 Month — Decrease1
1 Month — No Change6
1 Month — Increase18
6 Months — Decrease1
6 Months — No Change3
6 Months — Increase26
12 Months — Decrease0
12 Months — No Change7
12 Months — Increase24
24 Months — Decrease0
24 Months — No Change6
24 Months — Increase23
36 Months — Decrease0
36 Months — No Change4
36 Months — Increase18
48 Months — Decrease0
48 Months — No Change3
48 Months — Increase16
60 Months — Decrease0
60 Months — No Change3
60 Months — Increase18
PrimaryChange 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)

Time frame:
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)
Reported as:
Count of participants · Participants
Change in Minimum True Lumen Diameter Distal to Treated Segment
ParticipantsDissection
1 Month — Decrease0
1 Month — No Change13
1 Month — Increase11
6 Months — Decrease1
6 Months — No Change11
6 Months — Increase14
12 Months — Decrease0
12 Months — No Change10
12 Months — Increase16
24 Months — Decrease0
24 Months — No Change7
24 Months — Increase19
36 Months — Decrease0
36 Months — No Change5
36 Months — Increase15
48 Months — Decrease0
48 Months — No Change6
48 Months — Increase12
60 Months — Decrease0
60 Months — No Change7
60 Months — Increase13
PrimaryChange 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)

Time frame:
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)
Reported as:
Count of participants · Participants
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
ParticipantsDissection
1 Month — Decrease18
1 Month — No Change5
1 Month — Increase1
6 Months — Decrease23
6 Months — No Change4
6 Months — Increase0
12 Months — Decrease24
12 Months — No Change4
12 Months — Increase1
24 Months — Decrease21
24 Months — No Change2
24 Months — Increase2
36 Months — Decrease17
36 Months — No Change2
36 Months — Increase1
48 Months — Decrease15
48 Months — No Change2
48 Months — Increase1
60 Months — Decrease18
60 Months — No Change0
60 Months — Increase1
PrimaryChange 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)

Time frame:
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)
Reported as:
Count of participants · Participants
Change in Maximum False Lumen Diameter Distal to Treated Segment
ParticipantsDissection
1 Month — Decrease14
1 Month — No Change10
1 Month — Increase0
6 Months — Decrease19
6 Months — No Change5
6 Months — Increase1
12 Months — Decrease20
12 Months — No Change4
12 Months — Increase2
24 Months — Decrease15
24 Months — No Change6
24 Months — Increase2
36 Months — Decrease12
36 Months — No Change3
36 Months — Increase4
48 Months — Decrease14
48 Months — No Change1
48 Months — Increase2
60 Months — Decrease15
60 Months — No Change3
60 Months — Increase1
PrimaryChange in Maximum Lesion Diameter

Change in maximum lesion diameter at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)

Time frame:
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)
Reported as:
Count of participants · Participants
Change in Maximum Lesion Diameter
ParticipantsTrauma
6 Months — Decrease1
6 Months — No Change2
6 Months — Increase0
12 Months — Decrease1
12 Months — No Change2
12 Months — Increase0
24 Months — Decrease1
24 Months — No Change2
24 Months — Increase0
36 Months — Decrease1
36 Months — No Change0
36 Months — Increase0
48 Months — Decrease1
48 Months — No Change1
48 Months — Increase0
60 Months — Decrease1
60 Months — No Change0
60 Months — Increase0

Adverse events

Collected over 5 years (Post-operative day 0-2006). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dissection10/43 (23.3%)17/43 (39.5%)0/43 (0%)
Trauma1/12 (8.3%)1/12 (8.3%)0/12 (0%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventDissectionTrauma
Other Complications (not device complication)General disorders3/431/12
Congestive Heart FailureCardiac disorders3/430/12
Bowel IschemiaGastrointestinal disorders3/430/12
Aortic RuptureVascular disorders2/430/12
New Aortic DissectionVascular disorders2/430/12
Prosthesis InfectionInfections and infestations2/430/12
False Lumen Enlargement (>=5mm)Vascular disorders1/430/12
Atelactasis/PneumoniaRespiratory, thoracic and mediastinal disorders1/430/12
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/430/12
Other Bowel ComplicationGastrointestinal disorders1/430/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)DissectionTraumaTotal
Median65 (40 to 89)58.5 (20 to 79)65 (20 to 89)
Sex: Female, Male
Sex: Female, Male(Participants)DissectionTraumaTotal
Female10212
Male331043
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)DissectionTraumaTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)DissectionTraumaTotal
Japan431255
Height
Height(cm)DissectionTraumaTotal
Median165 (145 to 180)166.5 (155 to 182)165 (145 to 182)
Weight
Weight(kg)DissectionTraumaTotal
Median63.9 (30.3 to 94.8)67.3 (47.3 to 98.0)66.0 (30.3 to 98.0)
American Society of Anesthesiologists (ASA) Classification
American Society of Anesthesiologists (ASA) Classification(Participants)DissectionTraumaTotal
ASA 113316
ASA II10010
ASA III11516
ASA IV9413
ASA V000
Pulmonary Disease
Pulmonary Disease(Participants)DissectionTraumaTotal
Count of participants404

9 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Dec 2022, 83 months.

Results were first posted in Oct 2024, 1 year 9 months after primary completion.

Of 42 observational studies under Aortic Aneurysm, Thoracic, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 98. This study's 83 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2022
First posted
Jun 10, 2022
StartActual
Jan 5, 2016
Primary completionActual
Dec 23, 2022
CompletionActual
Dec 23, 2022
Results first posted
Oct 3, 2024
Last update
Oct 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05414318
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Jun 10, 2022
Start date
Jan 5, 2016
Primary completion
Dec 23, 2022
Completion
Dec 23, 2022
Results posted
Oct 3, 2024
Last update
Oct 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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