Trial Outcomes & Findings for ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection (NCT NCT02380716)
NCT ID: NCT02380716
Last Updated: 2025-06-19
Results Overview
Number of subjects that die of any cause within 30 days post-procedure
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
21 participants
Primary outcome timeframe
30 days post-procedure
Results posted on
2025-06-19
Participant Flow
Participant milestones
| Measure |
GORE® Ascending Stent Graft
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
Primary Endpoint Analyzed
|
19
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Baseline characteristics by cohort
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=93 Participants
|
|
Age, Continuous
|
76.2 years
STANDARD_DEVIATION 11.29 • n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 days post-procedureNumber of subjects that die of any cause within 30 days post-procedure
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=19 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
All Cause Mortality at 30 Days Post-procedure
|
3 Participants
|
SECONDARY outcome
Timeframe: At removal of device deployment system, up to conclusion of procedureNumber of subjects with technical success defined as successful access to the aorta, successful deployment of the study device components, successful retrieval of the device delivery system, exclusion of the primary entry tear of the aortic dissection, and patency of the side branch device component, if used.
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Successful Dissection Treatment (Technical Success)
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, and 12 months post procedureAssessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, and 12 months post procedureIndividual Components include: All Cause Mortality, Myocardial Infarction (MI), and Severe Stroke. Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee.
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Myocardial Infarction - 6 Months (183 Days)
|
0 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Myocardial Infarction - One Year (365 Days)
|
0 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
All Cause Mortality - Through 30 Days
|
3 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
All Cause Mortality - Through 6 Months (183 Days)
|
4 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
All Cause Mortality - Through 1 Year (365 Days)
|
4 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Myocardial Infarction - 30 Days
|
0 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Severe Stroke - 30 Days
|
2 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Severe Stroke - 6 Months (183 Days)
|
3 Participants
|
|
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Severe Stroke - One Year (365 Days)
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days post procedureAssessed by reported adverse events and adjudicated by a Clinical Events Committee
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Aorta-related Mortality
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, and 12 months post procedureAssessed on CT scans within the defined visits windows 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
30 Day Device Migration
|
0 Participants
|
|
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
6 Month (183) Device Migration
|
0 Participants
|
|
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
1 Year (365 Day) Device Migration
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, and 12 months post procedureAssessed on CT scans within the defined visits windows: 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure Definitions: Endoleak Type I (A and B): Endoleak arising at or from the prosthesis attachment site perfusing the treated region of the aorta. Endoleak Type IA: Endoleak at proximal aortic prosthesis attachment site. Endoleak Type IB: Endoleak at distal prosthesis attachment site. Endoleak Type II: Endoleak arising from a patent branch vessel of the excluded aorta perfusing the treated aorta, e.g., lumbar or inferior mesenteric branch. Endoleak Type III: Endoleak arising from the component junction(s) of the prosthesis or due to a defect in the graft material perfusing the treated region of the aorta. Endoleak Type IV: Endoleak arising through the graft fabric perfusing the treated region of the aorta. \*\*\*Endoleak categorizations have no directionality (i.e., cannot be considered better or worse)\*\*
Outcome measures
| Measure |
GORE® Ascending Stent Graft
n=21 Participants
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Any Endoleak - 1 Month
|
3 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Any Endoleak - 6 Month
|
4 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Any Endoleak - 12 Month
|
4 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IA Endoleak - 1 Month
|
3 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IA Endoleak - 6 Month
|
3 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IA Endoleak - 1 Year
|
3 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IB Endoleak - 1 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IB Endoleak - 6 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IB Endoleak - 12 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type II Endoleak - 1 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type II Endoleak - 6 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type II Endoleak - 12 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type III Endoleak - 1 Month
|
1 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type III Endoleak - 6 Month
|
2 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type III Endoleak - 12 Month
|
2 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IV Endoleak - 1 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IV Endoleak - 6 Month
|
0 Participants
|
|
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Type IV Endoleak - 12 Month
|
0 Participants
|
Adverse Events
GORE® Ascending Stent Graft
Serious events: 19 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
GORE® Ascending Stent Graft
n=21 participants at risk
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Infections and infestations
Influenza
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Bacteraemia
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Sepsis
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Urosepsis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Pyelonephritis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Metabolism and nutrition disorders
Malnutrition
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Metabolism and nutrition disorders
Acidosis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
1/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Psychiatric disorders
Mental Status Changes
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Nervous system disorders
Cerebrovascular Accident
|
23.8%
5/21 • Number of events 7 • Through 5 Years or Study Discontinuation/Completion
|
|
Nervous system disorders
Embolic Stroke
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Nervous system disorders
Encephalopathy
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Nervous system disorders
Monoplegia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Aortic Valve Incompetence
|
14.3%
3/21 • Number of events 3 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Atrioventricular Block
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Atrioventricular Block Complete
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Cardiac Failure
|
4.8%
1/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Cardiogenic Shock
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Cardiac Tamponade
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Bradycardia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Atrial Fibrilation
|
14.3%
3/21 • Number of events 4 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Ventricular Arrhythmia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Vascular disorders
Deep Vein Thrombosis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Vascular disorders
Aortic Rupture
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
14.3%
3/21 • Number of events 3 • Through 5 Years or Study Discontinuation/Completion
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Renal and urinary disorders
Urinary Retention
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
Renal and urinary disorders
Haematuria
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Renal and urinary disorders
Calculus Bladder
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Injury Associated with Device
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Death
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Infusion Site Extravasation
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Non-Cardiac Chest Pain
|
9.5%
2/21 • Number of events 2 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Stent-Graft Endoleak
|
14.3%
3/21 • Number of events 5 • Through 5 Years or Study Discontinuation/Completion
|
|
Injury, poisoning and procedural complications
Device Placement Issue
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Injury, poisoning and procedural complications
Weaning Failure
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Surgical and medical procedures
Arterial Puncture
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
Other adverse events
| Measure |
GORE® Ascending Stent Graft
n=21 participants at risk
Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft
|
|---|---|
|
Infections and infestations
Clostridium Difficile Colities
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Pneumonia Aspiration
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Psychiatric disorders
Mental Status Changes
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Nervous system disorders
Cerebrovascular Accident
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Palpitations
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Cardiac disorders
Sinus Tachycardia
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Vascular disorders
Accelerated Hypertension
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Vascular disorders
Aortic Dissection
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Vascular disorders
Shock
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Gastrointestinal disorders
Truncus Coeliacus Thrombosis
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Adverse Drug Reaction
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
General disorders
Stent-Graft Endoleak
|
19.0%
4/21 • Number of events 4 • Through 5 Years or Study Discontinuation/Completion
|
|
Injury, poisoning and procedural complications
Device Placement Issue
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Injury, poisoning and procedural complications
Incision Site Swelling
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Infections and infestations
Influenza
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.8%
1/21 • Number of events 1 • Through 5 Years or Study Discontinuation/Completion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place