Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Conditions
Brief summary
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
Detailed description
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries. The registry procedures consist of two phases, retrospective phase and prospective phase. The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature). The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
Interventions
DEVICEGORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Sponsors
W.L.Gore & Associates
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017 2. Age ≥18 years at the time of implant 3. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations.
Exclusion criteria
1. Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure 2. Patient treated for acute or sub-acute dissection, \<90 days from onset of symptoms 3. Patient treated using physician-modified endovascular grafts 4. Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan 5. At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment 6. Patient was pregnant at the time of treatment. 7. Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints. 8. Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Vessel Patency | 12 months | Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up. |
Countries
Denmark, Italy, Netherlands, Norway, Spain, Sweden
Participant flow
Recruitment details
There were 259 patients enrolled and divided as follows: 136 subjects in the BEVAR cohort, 92 in the FEVAR cohort and 31 in the MIXED cohort Fourteen investigators at 14 sites participated in the registry within 6 European countries. All the 14 sites are still active and enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| fEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | 92 |
| bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | 136 |
| fEVAR and bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | 31 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 5 | 35 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 | 0 |
| Overall Study | withdrawal | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | bEVAR | fEVAR and bEVAR | Total | fEVAR |
|---|---|---|---|---|
| Age, Continuous | 74 Years | 72 Years | 74 Years | 74 Years |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Denmark | 19 participants | 6 participants | 44 participants | 19 participants |
| Region of Enrollment Italy | 62 participants | 5 participants | 83 participants | 16 participants |
| Region of Enrollment Netherlands | 21 participants | 0 participants | 32 participants | 11 participants |
| Region of Enrollment Norway | 1 participants | 7 participants | 30 participants | 22 participants |
| Region of Enrollment Spain | 15 participants | 6 participants | 32 participants | 11 participants |
| Region of Enrollment Sweden | 18 participants | 7 participants | 38 participants | 13 participants |
| Serum Creatinine | 1.1 mg/dL | 0.9 mg/dL | 1.1 mg/dL | 1.1 mg/dL |
| Sex: Female, Male Female | 37 Participants | 14 Participants | 63 Participants | 12 Participants |
| Sex: Female, Male Male | 99 Participants | 17 Participants | 196 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 92 | 35 / 136 | 1 / 31 |
| other Total, other adverse events | 6 / 92 | 7 / 136 | 3 / 31 |
| serious Total, serious adverse events | 44 / 92 | 89 / 136 | 21 / 31 |
Outcome results
Primary
Number of Participants With Target Vessel Patency
Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.
Time frame: 12 months
Population: Study endpoints were planned and calculated for the two primary cohorts only. Subjects that are not discontinued prior to 1 year window and with imaging within 1 year window.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| fEVAR | Number of Participants With Target Vessel Patency | 78 Participants |
| bEVAR | Number of Participants With Target Vessel Patency | 84 Participants |