Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy will be evaluated by the device-related adverse event rate of endovascular repair (via Relay Thoracic Stent-Graft) through 1-year. Safety will be evaluated by comparing major adverse events through 1-year in subjects treated with the Relay Thoracic Stent-Graft to those who underwent surgical repair. Long term follow-up is conducted through 5 years.
Interventions
implant
PROCEDUREOpen Repair
Open surgery
Sponsors
Bolton Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers * Subjects who are at least 18 years of age * Subjects whose anatomy can accommodate the Relay device * Subjects who consent to participate * Subjects who agree to comply with follow-up schedule
Exclusion criteria
* Subjects with non-aneurysm lesions * Subjects with less than 1 year life expectancy * Subjects who are pregnant * Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.) * Subjects participating in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects | 1 year | The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met. |
| Primary Safety Endpoint: Distribution of Major Adverse Events | 1 year | The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure |
Countries
United States
Participant flow
Recruitment details
Subjects screened and enrolled at 29 sites in the United States
Participants by arm
| Arm | Count |
|---|---|
| Relay Device Group Endovascular Treatment arm | 120 |
| Surgical Control Group Open Surgical Repair arm | 60 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Conversion to Open Repair | 1 | 0 |
| Overall Study | Death | 17 | 10 |
| Overall Study | Lost to Follow-up | 0 | 16 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Technical Failure | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Surgical Control Group | Relay Device Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 48 Participants | 99 Participants | 147 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 21 Participants | 33 Participants |
| Age, Continuous | 70.0 years STANDARD_DEVIATION 9.17 | 72.8 years STANDARD_DEVIATION 11.02 | 71.84 years STANDARD_DEVIATION 10.39 |
| Region of Enrollment United States | 60 participants | 120 participants | 180 participants |
| Sex: Female, Male Female | 20 Participants | 58 Participants | 78 Participants |
| Sex: Female, Male Male | 40 Participants | 62 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 97 / 120 | 58 / 60 |
| serious Total, serious adverse events | 68 / 120 | 45 / 60 |
Outcome results
Primary
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Time frame: 1 year
Population: All subjects who underwent the Relay implant procedure (Intention to Treat)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relay Device Group | Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects | 97 participants |
Comparison: The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.p-value: >0.81-sided z-test
Primary
Primary Safety Endpoint: Distribution of Major Adverse Events
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Time frame: 1 year
Population: The number of subjects who underwent the endovascular procedure or open surgical repair
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Relay Device Group | Primary Safety Endpoint: Distribution of Major Adverse Events | 27 participants |
| Surgical Control Group | Primary Safety Endpoint: Distribution of Major Adverse Events | 51 participants |