Trial Outcomes & Findings for Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL (NCT NCT03286400)
NCT ID: NCT03286400
Last Updated: 2020-12-17
Results Overview
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Recruitment status
COMPLETED
Target enrollment
127 participants
Primary outcome timeframe
24 hours
Results posted on
2020-12-17
Participant Flow
Participant milestones
| Measure |
CTAG Device With ACTIVE CONTROL
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Overall Study
STARTED
|
127
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
CTAG Device With ACTIVE CONTROL
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Overall Study
Death
|
10
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Scheduling difficulty
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CTAG Device With ACTIVE CONTROL
n=127 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Age, Continuous
|
67.1 Years
STANDARD_DEVIATION 12.1 • n=127 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=127 Participants
|
|
Region of Enrollment
Netherlands
|
33 participants
n=127 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=127 Participants
|
|
Region of Enrollment
Italy
|
24 participants
n=127 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=127 Participants
|
|
Region of Enrollment
France
|
7 participants
n=127 Participants
|
|
Region of Enrollment
Germany
|
39 participants
n=127 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=127 Participants
|
PRIMARY outcome
Timeframe: 24 hoursSuccessful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=127 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Number of Subjects With Procedural Technical Success
|
123 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: Includes all subjects with treatment failure within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a treatment failure within 30 days and with less than 15 days of follow-up were not included in the analysis.
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=125 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Number of Subjects With Treatment Success at 30 Day Visit
|
115 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Includes all subjects with a Major Adverse Event within 30 days as well as subjects with at least 15 days of follow-up. Subjects without a Major Adverse Event within 30 days and with less than 15 days of follow-up were not included in the analysis.
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=116 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Number of Subjects With Freedom From Major Adverse Events at 30 Days
|
105 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Includes all subjects with a Major Adverse Event within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a Major Adverse Event within 12 months and with less than 275 days of follow-up were not included in the analysis.
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=102 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Number of Subjects With Freedom From Major Adverse Events at 12 Months
|
90 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: Includes all subjects with treatment failure within 12 months as well as subjects with at least 275 days of follow-up. Subjects without a treatment failure within 12 months and with less than 275 days of follow-up were not included in the analysis.
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=111 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Number of Subjects With Treatment Success at 12 Month Visit
|
97 Participants
|
SECONDARY outcome
Timeframe: Days 30, 365, and 455Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=127 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
30 Days
|
0.826 Probability
Interval 0.748 to 0.882
|
|
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
365 Days
|
0.699 Probability
Interval 0.609 to 0.772
|
|
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
455 Days
|
0.628 Probability
Interval 0.487 to 0.74
|
SECONDARY outcome
Timeframe: One yearPopulation: Includes all non-dissection subjects who have both post-procedure and 12-month measurements.
One year change from first post-implant CT scan in maximum aortic diameter
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=47 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
>= 5mm Decrease
|
20 Participants
|
|
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
No Change
|
22 Participants
|
|
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
>= 5mm Increase
|
5 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: Includes all dissection subjects who have both post-procedure and 12-month measurements.
One year change from first post-implant CT scan in maximum false lumen diameter
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=26 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Change in Maximum False Lumen Diameter Among Dissection
>= 5mm Decrease
|
15 Participants
|
|
Change in Maximum False Lumen Diameter Among Dissection
No Change
|
10 Participants
|
|
Change in Maximum False Lumen Diameter Among Dissection
>= 5mm Increase
|
1 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: Includes all dissection subjects who have both post-procedure and 12-month measurements.
One year change from first post-implant CT scan in minimum true lumen diameter
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=26 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Change in Minimum True Lumen Diameter Among Dissection
>= 5mm Decrease
|
5 Participants
|
|
Change in Minimum True Lumen Diameter Among Dissection
No Change
|
11 Participants
|
|
Change in Minimum True Lumen Diameter Among Dissection
>= 5mm Increase
|
10 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: Includes all dissection subjects who have both post-procedure and 12-month measurements.
One year change from first post-implant CT scan in maximum aortic diameter
Outcome measures
| Measure |
CTAG Device With ACTIVE CONTROL
n=26 Participants
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Change in Maximum Aortic Diameter Among Dissection
>= 5mm Decrease
|
14 Participants
|
|
Change in Maximum Aortic Diameter Among Dissection
No Change
|
10 Participants
|
|
Change in Maximum Aortic Diameter Among Dissection
>= 5mm Increase
|
2 Participants
|
Adverse Events
CTAG Device With ACTIVE CONTROL
Serious events: 45 serious events
Other events: 0 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
CTAG Device With ACTIVE CONTROL
n=127 participants at risk
All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL.
CTAG Device with ACTIVE CONTROL: Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Cardiac disorders
Palpitations
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Gastrointestinal disorders
Aorto-oesophageal fistula
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Gastrointestinal disorders
Constipation
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
General disorders
Death
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
General disorders
Stent-graft endoleak
|
7.1%
9/127 • Number of events 10 • 455 days
|
|
General disorders
Vascular stent occlusion
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Infections and infestations
Infective aneurysm
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Infections and infestations
Pneumonia
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Infections and infestations
Sepsis
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Infections and infestations
Urinary tract infection
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Infections and infestations
Vascular device infection
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Injury, poisoning and procedural complications
Vascular graft haemorrhage
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Metabolism and nutrition disorders
Cachexia
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Metabolism and nutrition disorders
Pancreatogenous diabetes
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Nervous system disorders
Carotid artery occlusion
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Nervous system disorders
Paraplegia
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Nervous system disorders
Spinal cord ischaemia
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Renal and urinary disorders
Renal failure
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic disorder
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
2/127 • Number of events 2 • 455 days
|
|
Vascular disorders
Aortic aneurysm
|
2.4%
3/127 • Number of events 3 • 455 days
|
|
Vascular disorders
Aortic dissection
|
2.4%
3/127 • Number of events 3 • 455 days
|
|
Vascular disorders
Aortic rupture
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Vascular disorders
Hypovolaemic shock
|
0.79%
1/127 • Number of events 1 • 455 days
|
|
Vascular disorders
Iliac artery stenosis
|
0.79%
1/127 • Number of events 1 • 455 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place