|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P040043 S051/ PAS002 |
Date Original Protocol Accepted |
11/20/2014
|
Date Current Protocol Accepted |
 
|
Study Name |
Comprehensive/Linked-Registry Based Surv
|
Device Name |
GORE TAG THORACIC ENDOPROSTHESIS
|
Clinical Trial Number(s) |
NCT00908388
|
General Study Protocol Parameters |
Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
Data Source |
External Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Detailed Study Protocol Parameters |
Study Objectives |
The purpose of this surveillance project, using the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) registry, will be to obtain data that can be used to refine the selection of and treatment strategy for patients with Type B aortic dissections managed through endovascular graft repair. Data will also be evaluated to identify any signals of device- specific safety or effectiveness issues. This project will be used to establish performance goals for future studies.
Specifically, the project will evaluate the short- and long-term clinical performance of endovascular grafts for the treatment of Type B thoracic aortic dissection, following premarket approval.
|
Study Population |
Inclusion criteria: Patients whose index procedure is on or after September 10, 2013 (date of first device approval) for treatment with an endovascular stent-graft used to repair Type B dissections in the descending thoracic aorta may be included in the 1-year or 5-year cohort.
Patients diagnosed with classic “double-barrel” Type B thoracic aortic dissection in the descending thoracic aorta and an identifiable intimal flap, with visible contrast enhancement in the false lumen that are treated with endovascular grafts at centers participating in the VQI registry.
For the 5-year cohort, subjects will be considered enrolled in the study after arterial cut- down and introduction of the endovascular graft. Data will be collected for unsuccessfully implanted patients through their in-hospital stay.
Exclusion criteria: Medial disruption with formation of intramural hematoma/hemorrhage.
Plaque rupture leading to aortic ulceration, penetrating aortic atherosclerotic ulcer with surrounding hematoma, usually subadventitial.
Iatrogenic and traumatic dissection.
|
Sample Size |
Two surveillance arms: a. Five (5)-year: Data will be captured on a minimum of 194 chronic and 200 acute patients with Device Technical Success, and treated at centers agreeing to participate in the Surveillance Project through the VQI registry. At least 60 patients treated with the final device design of a participating manufacturer will be enrolled in each surveillance arm (i.e., acute and chronic). If the total sample size of 200 or 194 patients has been reached for one arm (acute or chronic respectively) of the 5-year surveillance arm, but an individual device has not met the 60 patients minimum required for that arm, enrollment will only continue for that specific device.
b. One (1)-year: All-comers until 200 patients have been surveilled to the VQI registry during the specified enrollment period.
|
Key Study Endpoints |
The sponsor will report any significant observations from the surveillance described below of the use of the TAG device to repair Type B dissections in the descending thoracic aorta. Specifically, this surveillance should monitor: Primary Safety 5year arm: Freedom from dissection related mortality at 5 years 1year arm: Freedom from dissection related mortality through 1 year Primary Effectiveness 5 year arm: Device technical success at the time of the procedure (successful delivery, successful and accurate deployment, and successful withdrawal of the delivery system) Device procedural success at 30 days (device technical success with absence of the following at 30 days: major adverse events [MAE] subset, primary intimal tear false lumen perfusion [PIT FLP], retrograde extension of the dissection, and unintentional dissection septum rupture). 1 year arm: Device technical success at the time of the procedure (successful delivery, successful and accurate deployment, and successful withdrawal of the delivery system) Secondary endpoints 5 year arm: Elements of device technical and procedural success Additional endovascular and surgical dissection related interventions pre procedure, index procedure, and post index procedure (within 30 days, 1 year, yearly) The following endpoints at 30 days, 1 year, and yearly assessments: Dissection treatment success and its individual elements: -Aortic enlargement in the region encompassed by the initial dissection (1 year and yearly only) -Aortic rupture -Dissection-related mortality -Extension of the dissection (proximally or distally) with or without complications -False lumen perfusion (FLP): Primary intimal tear Proximal aorta Distal aorta Proximal branch Distal branch -Fistula formation (e.g., aorto-esophageal, aorto-tracheal) -MAEs subset -Unintentional dissection septum rupture Conservative estimate of dissection?related mortality All-cause mortality False lumen patency Endovascular device penetration of the aortic wall Loss of device integrity 1-year arm:Elements of device technical success
The following endpoints at procedure and 1 year assessments: FLP (all elements) Aortic enlargement in the region encompassed by the initial dissection (1 year only) Aortic rupture Dissection-related mortality Conservative estimate of dissection?related mortality All-cause mortality MAEs subset Additional endovascular and surgical dissection-related interventions Major adverse events are pre-specified as: paraplegia*+ paraparesis*+ disabling stroke* non-preexisting and sustained contrast?induced renal failure requiring dialysis not due to malperfusion of the kidneys present at presentation* new ischemia (i.e., not evident at the time of the index procedure) due to branch vessel compromise (malperfusion of organ, upper limb, or lower limb)+ *Subset of MAEs for device procedural success ++Subset of MAEs for dissection treatment success and 1-year arm
|
Follow-up Visits and Length of Follow-up |
5 year cohort: 30 days, 1 year, and annually through 5 years following the index procedure. 1 year cohort: 30 days and 1 year following the index procedure.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
246 subjects enrolled total: 5-year Acute cohort: 85 subjects 5-year Chronic cohort: 65 subjects 1-year Acute cohort: 48 subjects 1-year Chronic cohort: 29 subjects
|
Actual Number of Sites Enrolled |
37
|
Patient Follow-up Rate |
Any data | Imaging data 5 Year Acute Cohort at 1 year: 82.7% (62/75) | 57.3% (43/75) 5 Year Acute Cohort at 5 years: 68.3% (43/63) | 38.1% (24/63) 5 Year Chronic Cohort at 1 year: 87.1% (62/64) | 68.8% (44/64) 5 Year Chronic Cohort at 5 years: 67.3% (37/55) | 43.6% (24/55) 1 Year Acute Cohort at 1 year: 82.1% (32/39) | 61.5% (24/39) 1 Year Chronic Cohort at 1 year: 88.9% (24/27) | 70.4% (19/27)
|
Final Safety Findings |
N/A - Data for the primary safety endpoints were collected for all study devices combined; device-specific safety data is not available for presentation.
|
Final Effect Findings |
Primary Effectiveness: Device Technical Success during procedure: 5 Year Acute: 98.8% (84/85) 5 Year Chronic: 100% (64/64) 1 Year Acute: 91.7% (44/48) 1 Year Chronic: 100% (29/29) Device Procedural Success at 30 days: 5 Year Acute: 93.4% (71/76) 5 Year Chronic: 91.9% (57/62)
Secondary Endpoints:
Technical Success Elements (5 Year Acute | 5 Year Chronic) Successful device delivery: 98.8% | 100% Successful and accurate deployment: 98.8% | 100% Successful withdrawal of delivery system: 100% | 100% Procedural Success Elements (5 Year Acute | 5 Year Chronic) Freedom from retrograde extension of dissection: 96.8% | 100% Freedom from unintentional dissection septum rupture: 100% | 100% Freedom from PIT FLP: 96.5% | 88.1% Freedom from the subset of MAE: 98.7% | 100%
KM estimate of freedom from dissection-related interventions (5 Year Acute | 5 Year Chronic) Through 1 year: 87.5% (SE=4.2%) | 87.2% (SE=4.8%) Through 5 years: 77.6% (SE=6.2%) | 83.4% (SE=5.8%)
Dissection Treatment Success Elements (5 Year Acute | 5 Year Chronic) Freedom from aortic enlargement in the region encompassed by the treated section (range across all timepoints): 57.1-71.4% | 47.8-66.7% Freedom from aortic rupture: 100% | 100% KM estimate of freedom from dissection-related mortality: Through 1 year: 94.1% (SE=2.6%) | 98.5% (SE=1.5%) Through 5 years: 90.0% (SE=3.4%) | 98.5% (SE=1.5%) Freedom from extension of the dissection (range across all timepoints): 88.6-100% | 95-100% KM estimate of freedom from all-cause mortality: Through 1 year: 83.5% (SE=4.0%) | 95.4% (2.6%) Through 5 years: 71% (SE=5%) | 84.1% (SE=4.6%) False lumen thrombosis (range across all timepoints): 68.8-91.8% | 58.6-93.3% Loss of device integrity (range across all timepoints): 0-3.7% | 0-4.2%
1 Year Cohort Endpoints (1 Year Acute | 1 Year Chronic) Aortic enlargement in the region encompassed by the initial dissection at 1 year: 21.7% | 15.8% Aortic rupture at discharge: 2.1% | 0% Aortic rupture at 1 year: 0% | 0% KM estimate of freedom from dissection-related mortality through 1 year: 93.7% (SE=3.5%) | 100% KM estimate of freedom from all-cause mortality through 1 year: 83.3% (SE=5.4%) | 89.3% (SE=5.8%) KM estimate of freedom from dissection-related interventions through 1 year: 85.7% (SE=5.4%) | 88.4% (SE=6.4%) MAE subset (1 Year Acute at discharge / at 1 year | 1 Year Chronic at discharge / at 1 year) Paraplegia: 4.2% / 0% | 0% / 0% Paraparesis: 0% / 0% | 3.4% / 0% Stroke or transient ischemic attack: 6.2% / 0% | 0% / 0% Spinal cord deficit: 2.1% / 0% | 6.9% / 0% Lower limb ischemia: 2.1% / 0% | 0% / 0% Mesenteric ischemia: 0% / 0% | 3.4% / 0%
|
Study Strengths & Weaknesses |
Strengths: Study gathers and separately presents results on acute and chronic dissections through five years, represents geographically diverse health centers in the US, includes representation of some patients with connective tissue disorders, and maintains standard definitions and reporting among the manufacturers participating in the registry. The study compares patient baseline characteristics and outcomes between the VQI study sites and the all-comer VQI population. Weaknesses: The follow-up compliance, particularly for imaging data, is very low, which leads to uncertainty in the longer-term outcomes due to a large portion of missing data. Enrollment of subjects in the 5-year cohorts was non-consecutive, which may introduce selection bias. The study sample size is not powered to determine event rates for each device. The patient population treated was heavily represented by male (73.1%) and Caucasian (59.9%) patients, with reasonable representation from female (26.9%) and African American (29.5%) patients. Limited data was available for other races or ethnicities.
|
Recommendations for Labeling Changes |
Labeling changes are recommended to present the long-term outcomes of this device while acknowledging the limitations of this post-market registry.
|