Aortic Dissection
Conditions
Keywords
type A dissection
Brief summary
Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
Detailed description
This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.
Interventions
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including: * Primary entry tear must be in the ascending aorta and ≥2cm distal to the most distal coronary artery ostia * Ascending aorta compatible with the GORE® Ascending Stent Graft including landing zone true lumen diameter between 24mm - 42mm and total aortic landing zone diameter ≤ 45 mm 2. Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure 3. High surgical risk, as determined by the implanting physician 4. Adequate vascular access via transfemoral or retroperitoneal approach 5. An Informed Consent Form signed by Subject or legally authorized representative 6. Able to comply with protocol requirements including follow-up
Exclusion criteria
1. Planned aortic valve repair or replacement or coronary artery intervention within 30 days 2. Presence of mechanical heart valve in the aortic position 3. Primary entry tear location in the aortic arch or descending thoracic aorta with retrograde flow into the ascending aorta 4. Aortic insufficiency grade 3+ or 4+ 5. Known irreversible neurological injury 6. Known degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 7. Participation in another drug or medical device study within 1 year of study enrollment 8. Known history of drug abuse 9. Pregnant female at time of informed consent signature 10. Body habitus or other medical condition which prevents adequate visualization of the aorta 11. Systemic infection that could increase the risk of endovascular graft infection 12. Previous thoracic aortic surgery 13. Life expectancy \<12 months due to associated non-cardiac co-morbid conditions 14. Subject has known sensitivities or allergies to the device materials 15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 16. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality at 30 Days Post-procedure | 30 days post-procedure | Number of subjects that die of any cause within 30 days post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Dissection Treatment (Technical Success) | At removal of device deployment system, up to conclusion of procedure | Number 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. |
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months | 30 days, 6 months, and 12 months post procedure | Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee |
| Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | 30 days, 6 months, and 12 months post procedure | Individual 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. |
| Aorta-related Mortality | 30 days post procedure | Assessed by reported adverse events and adjudicated by a Clinical Events Committee |
| Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months | 30 days, 6 months, and 12 months post procedure | Assessed 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 |
| Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | 30 days, 6 months, and 12 months post procedure | Assessed 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)\*\* |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® Ascending Stent Graft Treatment with the GORE® Ascending Stent Graft
GORE® Ascending Stent Graft | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | GORE® Ascending Stent Graft |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 76.2 years STANDARD_DEVIATION 11.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 21 |
| other Total, other adverse events | 9 / 21 |
| serious Total, serious adverse events | 19 / 21 |
Outcome results
Primary
All Cause Mortality at 30 Days Post-procedure
Number of subjects that die of any cause within 30 days post-procedure
Time frame: 30 days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® Ascending Stent Graft | All Cause Mortality at 30 Days Post-procedure | 3 Participants |
Secondary
Aorta-related Mortality
Assessed by reported adverse events and adjudicated by a Clinical Events Committee
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® Ascending Stent Graft | Aorta-related Mortality | 3 Participants |
Secondary
Endoleak Assessed Through 1 Month, 6 Months, and 12 Months
Assessed 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)\*\*
Time frame: 30 days, 6 months, and 12 months post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Any Endoleak - 1 Month | 3 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Any Endoleak - 6 Month | 4 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Any Endoleak - 12 Month | 4 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IA Endoleak - 1 Month | 3 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IA Endoleak - 6 Month | 3 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IA Endoleak - 1 Year | 3 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IB Endoleak - 1 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IB Endoleak - 6 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IB Endoleak - 12 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type II Endoleak - 1 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type II Endoleak - 6 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type II Endoleak - 12 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type III Endoleak - 1 Month | 1 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type III Endoleak - 6 Month | 2 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type III Endoleak - 12 Month | 2 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IV Endoleak - 1 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IV Endoleak - 6 Month | 0 Participants |
| GORE® Ascending Stent Graft | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Type IV Endoleak - 12 Month | 0 Participants |
Secondary
Individual MACCE Components Through 30 Days, 6 Months, and 12 Months
Individual 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.
Time frame: 30 days, 6 months, and 12 months post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | All Cause Mortality - Through 30 Days | 3 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | All Cause Mortality - Through 6 Months (183 Days) | 4 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | All Cause Mortality - Through 1 Year (365 Days) | 4 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Myocardial Infarction - 30 Days | 0 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Myocardial Infarction - 6 Months (183 Days) | 0 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Myocardial Infarction - One Year (365 Days) | 0 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Severe Stroke - 30 Days | 2 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Severe Stroke - 6 Months (183 Days) | 3 Participants |
| GORE® Ascending Stent Graft | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Severe Stroke - One Year (365 Days) | 3 Participants |
Secondary
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months
Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee
Time frame: 30 days, 6 months, and 12 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® Ascending Stent Graft | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months | 9 Participants |
Secondary
Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months
Assessed 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
Time frame: 30 days, 6 months, and 12 months post procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 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 |
| GORE® Ascending Stent Graft | Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months | 6 Month (183) Device Migration | 0 Participants |
| GORE® Ascending Stent Graft | Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months | 1 Year (365 Day) Device Migration | 0 Participants |
Secondary
Successful Dissection Treatment (Technical Success)
Number 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.
Time frame: At removal of device deployment system, up to conclusion of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® Ascending Stent Graft | Successful Dissection Treatment (Technical Success) | 17 Participants |