Thoracic Aortic AneurysmNCT05414318

CTAG Dissection/Trauma Post Marketing Surveillance Japan

An observational study of Thoracic Aortic Aneurysm and Thoracic Aorta Injury, run by W.L.Gore & Associates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis Read more about this study

Who is it for?: Any age
Conditions the study is for: Thoracic Aortic Aneurysm, Thoracic Aorta Injury, Thoracic Aortic Dissection
What is being tested?: Conformable GORE® TAG® Thoracic Endoprosthesis
Type of treatment: Medical device
How many people: 55 participants
Where: No sites listed yet
Study dates: 5 Jan 2016to 23 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Who may be able to join

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

Who cannot join

None listed.

About this study

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

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

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.

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)
Aortic Rupture
Number of subjects with Aortic Rupture
Measured: Procedure through 5 years (Day 0-2006)
Major Device-related Adverse Events
Number of subjects with major device-related adverse events
Measured: Procedure through 5 years (Day 0-2006)
Secondary Intervention Treatment
Incidence rate of secondary intervention treatment
Measured: Post-procedure through 5 years (Day 1-2006)
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)
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)
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)
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)
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.

5 Jan 201623 Dec 2022

First posted10 Jun 2022
Study start5 Jan 2016
Primary completion23 Dec 2022
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.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05414318
Sponsor's protocol ID: JPS 16-01
Status last verified: Jun 2024
First submitted: 7 Jun 2022
Last updated: 3 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

All Thoracic Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG)
ClinicalTrials.gov ID: NCT05414318
Acronym / sponsor ID: JPS 16-01
Conditions: Thoracic Aortic Aneurysm, Thoracic Aorta Injury, Thoracic Aortic Dissection
Study type: Observational
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: 5 Jan 2016 (actual)
Primary completion: 23 Dec 2022 (actual)
Study completion: 23 Dec 2022 (actual)
First posted: 10 Jun 2022 (actual)
Results: Posted 3 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: 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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conformable GORE® TAG® Thoracic EndoprosthesisThoracic Endoprosthesis	Device	–

Primary outcome

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)
Number of subjects who achieved the primary entry tear exclusion
Aortic Rupture
Time frame: Procedure through 5 years (Day 0-2006)
Number of subjects with Aortic Rupture
Major Device-related Adverse Events
Time frame: Procedure through 5 years (Day 0-2006)
Number of subjects with major device-related adverse events
Secondary Intervention Treatment
Time frame: Post-procedure through 5 years (Day 1-2006)
Incidence rate of secondary intervention treatment
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
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)
Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)
Change in Minimum True Lumen Diameter Distal to Treated Segment
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)
Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
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)
Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)
Change in Maximum False Lumen Diameter Distal to Treated Segment
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)
Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)
Change in Maximum Lesion Diameter
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)
Change in maximum lesion diameter at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm)

Results and safety

Results posted to the registry on 3 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dissection	43	21
Trauma	12	5

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Dissection n = 38
1 Month	21
6 Months	26
12 Months	27
24 Months	22
36 Months	19
48 Months	17
60 Months	20

Population analysed: Patients with acute complicated Stanford type B dissection with evaluable result. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated)

Primary outcome: Aortic Rupture

Time frame: Procedure through 5 years (Day 0-2006). Count of participants. Unit: Participants

Measure	Dissection n = 43
Value	2

Population analysed: Subjects with acute complicated Stanford type B dissection. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated)

Primary outcome: Major Device-related Adverse Events

Time frame: Procedure through 5 years (Day 0-2006). Count of participants. Unit: Participants

Measure	Dissection n = 43	Trauma n = 12
Value	3	0

Primary outcome: Secondary Intervention Treatment

Time frame: Post-procedure through 5 years (Day 1-2006). Count of participants. Unit: Participants

Measure	Dissection n = 42	Trauma n = 12
Value	5	0

Adverse events

Time frame: 5 years (Post-operative day 0-2006). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dissection	17 of 43 (39.5%)	0 of 43 (0%)	10 of 43
Trauma	1 of 12 (8.3%)	0 of 12 (0%)	1 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Thoracic Aortic Aneurysm

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Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
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Recruiting
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Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
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Not yet recruitingPhase 4
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Thoracic Aortic Aneurysm and Thoracic Aorta Injury, run by W.L.Gore & Associates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05414318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.