CTAG Dissection/Trauma Post Marketing Surveillance Japan

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05414318

Enrollment

Registered

2022-06-10

Start date

2016-01-05

Completion date

2022-12-23

Last updated

2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Aorta Injury, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection

Brief summary

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

Interventions

DEVICEConformable GORE® TAG® Thoracic Endoprosthesis

Thoracic Endoprosthesis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Entry Tear Exclusion	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	Procedure through 5 years (Day 0-2006)	Number of subjects with Aortic Rupture
Major Device-related Adverse Events	Procedure through 5 years (Day 0-2006)	Number of subjects with major device-related adverse events
Secondary Intervention Treatment	Post-procedure through 5 years (Day 1-2006)	Incidence rate of secondary intervention treatment
Change in Minimum True Lumen Diameter Adjacent to Treated Segment	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	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	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	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	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)

Participant flow

Participants by arm

Arm	Count
Dissection Acute complicated Stanford type B dissection	43
Trauma Traumatic thoracic aortic injury	12
Total	55

Baseline characteristics

Characteristic	Dissection	Trauma	Total
Age, Continuous	65 years	58.5 years	65 years
American Society of Anesthesiologists (ASA) Classification ASA 1	13 Participants	3 Participants	16 Participants
American Society of Anesthesiologists (ASA) Classification ASA II	10 Participants	0 Participants	10 Participants
American Society of Anesthesiologists (ASA) Classification ASA III	11 Participants	5 Participants	16 Participants
American Society of Anesthesiologists (ASA) Classification ASA IV	9 Participants	4 Participants	13 Participants
American Society of Anesthesiologists (ASA) Classification ASA V	0 Participants	0 Participants	0 Participants
At Risk for Graft Infection	0 Participants	1 Participants	1 Participants
Bowel Necrosis	1 Participants	0 Participants	1 Participants
Cerebrovascular Disease	6 Participants	0 Participants	6 Participants
Degenerative Connective Tissue Disease	1 Participants	0 Participants	1 Participants
Diabetes Mellitus	5 Participants	1 Participants	6 Participants
Height	165 cm	166.5 cm	165 cm
Hypertension	29 Participants	2 Participants	31 Participants
Persistent Refractory Shock	3 Participants	2 Participants	5 Participants
Prior Descending Thoracic Aorta Repair	0 Participants	0 Participants	0 Participants
Pulmonary Disease	4 Participants	0 Participants	4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment Japan	43 participants	12 participants	55 participants
Renal Disease	2 Participants	0 Participants	2 Participants
Sex: Female, Male Female	10 Participants	2 Participants	12 Participants
Sex: Female, Male Male	33 Participants	10 Participants	43 Participants
Weight	63.9 kg	67.3 kg	66.0 kg

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	10 / 43	1 / 12
other Total, other adverse events	0 / 43	0 / 12
serious Total, serious adverse events	17 / 43	1 / 12

Outcome results

Primary

Aortic Rupture

Number of subjects with Aortic Rupture

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Dissection	Aortic Rupture	2 Participants

Primary

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)

Population: Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	1 Month	Decrease	18 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	1 Month	No Change	5 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	1 Month	Increase	1 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	6 Months	Decrease	23 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	6 Months	No Change	4 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	6 Months	Increase	0 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	12 Months	Decrease	24 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	12 Months	No Change	4 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	12 Months	Increase	1 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	24 Months	Decrease	21 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	24 Months	No Change	2 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	24 Months	Increase	2 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	36 Months	Decrease	17 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	36 Months	No Change	2 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	36 Months	Increase	1 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	48 Months	Decrease	15 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	48 Months	No Change	2 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	48 Months	Increase	1 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	60 Months	Decrease	18 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	60 Months	No Change	0 Participants
Dissection	Change in Maximum False Lumen Diameter Adjacent to Treated Segment	60 Months	Increase	1 Participants

Primary

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)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	1 Month	Decrease	14 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	1 Month	No Change	10 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	1 Month	Increase	0 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	6 Months	Decrease	19 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	6 Months	No Change	5 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	6 Months	Increase	1 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	12 Months	Decrease	20 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	12 Months	No Change	4 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	12 Months	Increase	2 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	24 Months	Decrease	15 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	24 Months	No Change	6 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	24 Months	Increase	2 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	36 Months	Decrease	12 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	36 Months	No Change	3 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	36 Months	Increase	4 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	48 Months	Decrease	14 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	48 Months	No Change	1 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	48 Months	Increase	2 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	60 Months	Decrease	15 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	60 Months	No Change	3 Participants
Dissection	Change in Maximum False Lumen Diameter Distal to Treated Segment	60 Months	Increase	1 Participants

Primary

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)

Population: Subjects with Traumatic thoracic aortic injury. (Outcome not applicable for dissection arm - see Outcome Measures #5-8 for change in true/false lumen diameter for the dissection arm)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dissection	Change in Maximum Lesion Diameter	6 Months	Decrease	1 Participants
Dissection	Change in Maximum Lesion Diameter	6 Months	No Change	2 Participants
Dissection	Change in Maximum Lesion Diameter	6 Months	Increase	0 Participants
Dissection	Change in Maximum Lesion Diameter	12 Months	Decrease	1 Participants
Dissection	Change in Maximum Lesion Diameter	12 Months	No Change	2 Participants
Dissection	Change in Maximum Lesion Diameter	12 Months	Increase	0 Participants
Dissection	Change in Maximum Lesion Diameter	24 Months	Decrease	1 Participants
Dissection	Change in Maximum Lesion Diameter	24 Months	No Change	2 Participants
Dissection	Change in Maximum Lesion Diameter	24 Months	Increase	0 Participants
Dissection	Change in Maximum Lesion Diameter	36 Months	Decrease	1 Participants
Dissection	Change in Maximum Lesion Diameter	36 Months	No Change	0 Participants
Dissection	Change in Maximum Lesion Diameter	36 Months	Increase	0 Participants
Dissection	Change in Maximum Lesion Diameter	48 Months	Decrease	1 Participants
Dissection	Change in Maximum Lesion Diameter	48 Months	No Change	1 Participants
Dissection	Change in Maximum Lesion Diameter	48 Months	Increase	0 Participants
Dissection	Change in Maximum Lesion Diameter	60 Months	Decrease	1 Participants
Dissection	Change in Maximum Lesion Diameter	60 Months	No Change	0 Participants
Dissection	Change in Maximum Lesion Diameter	60 Months	Increase	0 Participants

Primary

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)

Population: Patients with acute complicated Stanford type B dissection with evaluable result. (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	1 Month	Decrease	1 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	1 Month	No Change	6 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	1 Month	Increase	18 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	6 Months	Decrease	1 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	6 Months	No Change	3 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	6 Months	Increase	26 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	12 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	12 Months	No Change	7 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	12 Months	Increase	24 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	24 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	24 Months	No Change	6 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	24 Months	Increase	23 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	36 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	36 Months	No Change	4 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	36 Months	Increase	18 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	48 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	48 Months	No Change	3 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	48 Months	Increase	16 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	60 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	60 Months	No Change	3 Participants
Dissection	Change in Minimum True Lumen Diameter Adjacent to Treated Segment	60 Months	Increase	18 Participants

Primary

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)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	1 Month	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	1 Month	No Change	13 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	1 Month	Increase	11 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	6 Months	Decrease	1 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	6 Months	No Change	11 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	6 Months	Increase	14 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	12 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	12 Months	No Change	10 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	12 Months	Increase	16 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	24 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	24 Months	No Change	7 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	24 Months	Increase	19 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	36 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	36 Months	No Change	5 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	36 Months	Increase	15 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	48 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	48 Months	No Change	6 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	48 Months	Increase	12 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	60 Months	Decrease	0 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	60 Months	No Change	7 Participants
Dissection	Change in Minimum True Lumen Diameter Distal to Treated Segment	60 Months	Increase	13 Participants

Primary

Major Device-related Adverse Events

Number of subjects with major device-related adverse events

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Dissection	Major Device-related Adverse Events	3 Participants
Trauma	Major Device-related Adverse Events	0 Participants

Primary

Primary Entry Tear Exclusion

Number of subjects who achieved the primary entry tear exclusion

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Dissection	Primary Entry Tear Exclusion	1 Month	21 Participants
Dissection	Primary Entry Tear Exclusion	6 Months	26 Participants
Dissection	Primary Entry Tear Exclusion	12 Months	27 Participants
Dissection	Primary Entry Tear Exclusion	24 Months	22 Participants
Dissection	Primary Entry Tear Exclusion	36 Months	19 Participants
Dissection	Primary Entry Tear Exclusion	48 Months	17 Participants
Dissection	Primary Entry Tear Exclusion	60 Months	20 Participants

Primary

Secondary Intervention Treatment

Incidence rate of secondary intervention treatment

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Dissection	Secondary Intervention Treatment	5 Participants
Trauma	Secondary Intervention Treatment	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

CTAG Dissection/Trauma Post Marketing Surveillance Japan

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Design outcomes

Primary

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Aortic Rupture

Change in Maximum False Lumen Diameter Adjacent to Treated Segment

Change in Maximum False Lumen Diameter Distal to Treated Segment

Change in Maximum Lesion Diameter

Change in Minimum True Lumen Diameter Adjacent to Treated Segment

Change in Minimum True Lumen Diameter Distal to Treated Segment

Major Device-related Adverse Events

Primary Entry Tear Exclusion

Secondary Intervention Treatment