Type B Aortic Dissection
Conditions
Keywords
Acute, Complicated Type B Dissection
Brief summary
The primary objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute complicated type B aortic dissection.
Interventions
Endoprosthetic Implant
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Presence of acute complicated type B aortic dissection: * Dissection is acute Time from symptom onset to dissection diagnosis ≤14 days * Dissection is complicated Subject must present with at least one of the following: * Rupture in the setting of an aortic dissection defined as hemorrhage outside of the aortic boundaries -which is noted by CT scan (hemorrhage must be differentiated from reactive effusions by the investigator, or if equivocal, having elevated Hounsefield units as determined by the radiologist). * Clinical evidence of malperfusion, in the setting of an aortic dissection, defined as: * Clinical or radiographic evidence of visceral hypoperfusion. * Clinical or radiographic evidence of renal hypoperfusion. * Clinical or radiographic evidence of lower extremity hypoperfusion. * Clinical or radiographic evidence of spinal cord hypoperfusion. * Dissection is type B Entire dissection is distal to the left subclavian artery * Primary Treatment Indication is Class 1 Aortic Dissection 46 Classical aortic dissection with intimal flap between true and false lumen with double barrel flow in thoracic aorta * Subjects with multiple entry tears are allowed to be enrolled in the study 2. Age 18 to 80 years 3. Primary treatment is endovascular treatment with the CTAG device. Adjunctive treatments may include left subclavian artery revascularization, percutaneous fenestration, aortic stenting, peripheral vessel stenting, surgical fenestration, and/or peripheral artery bypass 4. Proximal landing zone characteristics include: * Proximal extent of intended proximal landing zone cannot be dissected * Length ≥ 2.0 cm proximal to the primary entry tear * Trans-aortic diameter at proximal extent of intended landing zone between 16-42 mm (diameter assessed by flow lumen and thrombus, if present; calcium excluded) * Cannot be aneurysmal, heavily calcified, or have excessive intraluminal thrombus * Must be native aorta * May include left subclavian artery, if necessary 5. Subject is capable of complying with protocol requirements, including follow-up 6. Informed Consent Form is signed by subject or legal representative
Exclusion criteria
1. Primary treatment indication is Class 2-5 aortic dissection (intramural hematoma, limited dissection, penetrating atherosclerotic ulcer, iatrogenic dissection, traumatic dissection) 46 2. Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair (dissection extension into the abdominal aorta is acceptable) 3. Prior repair of DTA 4. Infected aorta 5. Subject has a systemic infection and may be at increased risk of endovascular graft infection 6. Persistent refractory shock (systolic blood pressure \<90 mm Hg) 7. Bowel necrosis (Bowel necrosis will be characterized by direct observation with surgical exploration, or elevated serum lactate level and CT findings of portal venous gas, free intra-abdominal gas, pneumatosis intramural gas, and poor mucosal enhancement of thickened bowel wall) 8. Renal failure , defined as baseline creatinine ≥ 2.5 mg/dl 9. ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation) 10. Pregnant female 11. Major surgery within 30 days of treatment (other than left subclavian artery bypass or transposition) 12. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome 13. Treatment in another drug or medical device study within 1 year of study enrollment 14. History of stimulant abuse, e.g., cocaine or amphetamine, within 1 year of treatment 15. Tortuous or stenotic iliac and/or femoral arteries and the inability to use a conduit for vascular access 16. Planned coverage of left carotid or celiac arteries with the CTAG device 17. The planned endovascular procedure involves alterations to the CTAG device 18. Subject has known sensitivities or allergies to the device materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality Incidence Through 30 Days Post-treatment | 30 Days Post-Treatment | — |
| Exclusion of Primary Entry Tear | 1 month | Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| False Lumen Thrombosis | Last available follow-up through 5 years | Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device. |
| Aortic Rupture | Last available follow-up through 5 years | Number of participants with thoracic aortic rupture |
| Additional Dissection Based Intervention Rate | Last available follow-up through 5 years | Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE Conformable TAG® Device Surgical Implant Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | GORE Conformable TAG® Device Surgical Implant |
|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 50 |
| other Total, other adverse events | 42 / 50 |
| serious Total, serious adverse events | 38 / 50 |
Outcome results
Primary
All-cause Mortality Incidence Through 30 Days Post-treatment
Time frame: 30 Days Post-Treatment
Population: All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | All-cause Mortality Incidence Through 30 Days Post-treatment | 5 participants |
p-value: 0.006Bayesian adaptive
Primary
Exclusion of Primary Entry Tear
Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | Exclusion of Primary Entry Tear | 39 participants |
Secondary
Additional Dissection Based Intervention Rate
Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.
Time frame: Last available follow-up through 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | Additional Dissection Based Intervention Rate | 9 participants |
Secondary
Aortic Rupture
Number of participants with thoracic aortic rupture
Time frame: Last available follow-up through 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | Aortic Rupture | 2 participants |
Secondary
False Lumen Thrombosis
Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.
Time frame: Last available follow-up through 5 years
Population: Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE Conformable TAG® Device Surgical Implant | False Lumen Thrombosis | Complete Thrombosis | 38 participants |
| GORE Conformable TAG® Device Surgical Implant | False Lumen Thrombosis | Partial Thrombosis | 6 participants |
| GORE Conformable TAG® Device Surgical Implant | False Lumen Thrombosis | Unknown | 1 participants |