Aneurysm
Conditions
Brief summary
To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use. To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.
Detailed description
The ZEPHYR registry has two major objectives: 1. to prospectively collect 'real world' safety, durability and clinical performance data on the Zenith AlphaTM Abdominal Endovascular Graft in subjects with infrarenal abdominal aortic or aorto-iliac aneurysms. 2. To increase the clinical evidence about the safety and effectiveness of the Zenith AlphaTM Abdominal Endovascular Graft by creating a database that can be pooled and/or compared with databases available on this and other stent graft systems. The ZEPHYR registry is a multi-center, post-market, non-randomized, single-arm prospective study. The study has no controls, as it is descriptive in nature. It will recruit approximately 450 subjects from high-volume sites across Germany and the BeNeLux. Study is open to consecutively enrolled subjects (20-50 per site) whou in the opinion of the investigator are candidates for endovascular AAA repair. The sites are recommended to schedule the subject's post-operative follow-up visits based on the current standard care in endovascular aneurysm repair (EVAR) therapy, which is generally at 1 month, 1 year and annually thereafter.
Interventions
PROCEDUREZenith Alpha Abdominal stentgraft
Sponsors
Syntactx
Philippe Cuypers
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years or minimum age as required by local regulations * Non-ruptured AAA with maximum diameter ≥50mm or enlargement \>5mm over 6 months and neck length ≥10mm (site-reported) * Elective EVAR * Intention to electively implant the Zenith AlphaTM AAA Endovascular Graft * Signed informed consent form
Exclusion criteria
* Intolerance to contrast media * High probability of non-adherence to physician's follow-up requirements * Current participation in a concurrent trial which may confound study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful treatment | 1 year | Proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | at 1 month, 1 year and at 2 years | All-cause mortality |
| Major adverse events | at 1 month, 1 year and at 2 years | all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, procedural blood loss \>1000 cc, renal failure requiring dialysis, respiratory failure, stroke |
| Aneurysm related mortality | up to 30 days after index procedure or within 30 days after aneurysm-related reintervention | death from rupture, device-related death, death within 30 days of index procedure, death within 30 days of any aneurysm-related reintervention |
| Stent graft migration of >5mm (with 30 days measurement as baseline) | at 1 year and at 2 years | Stent graft migration of \>5mm (with 30 days measurement as baseline) |
| Endoleak | at initial procedure, 1 month, 1 year and at 2 years | Any type of endoleak; tabulated by type (Ia, Ib, II or III) |
| Amount of secondary procedures to correct endoleaks | From the day after the initial procedure up to 2 years after the initail procedure (which is the end of the follow up period for this registry) | Secondary procedures to correct endoleaks |
| Treatment success | 1 month | Proportion of subjects who experience successful treatment at 1 month post-implant; defined by technical success and clinical success. |
| Amount of secondary surgical interventions for stent graft infection | From the day after the initial procedure up to 2 years after the initail procedure which is the end of the follow up period | Amount of secondary surgical intervention for stent graft infection |
| Amount of major lower limb amputation | From the day after the initial procedure up to 2 years after the initail procedure (which is the end of the follow up period for this registry) | Amount of major lower limb amputation |
| Which kind of vascular access is used during surgical intervention | at the primary procedure | Vascular access can either be unilateral, bilateral, open access or percutaneus access |
| Access site complications | during procedure up to 45 days | Hematoma, false aneurysm, vessel injury, primary conversion to femoral cutdown, surgical reintervention postoperative, false aneurysm at puncture site |
| Amount of secondary open surgical interventions | From the day after the initial procedure up to 2 years after the initail procedure (which is the end of the follow up period of this registry) | Amount of secondary open surgical interventions |
| Amount of secondary procedures for occlusion and/or kinking to restore stent graft function (endovascular and open procedures) | From the day after the initial procedure up to 2 years after the initail procedure which is the end of the follow up period | Amount of secondary procedures for occlusion/kinking to restore stent graft function (endovascular and open surgical procedures) |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed