Clinical trial NCT03165279: ZEnith AlPHa for AneurYsm Repair
Official title: ZEnith AlPHa for AneurYsm Repair (ZEPHYR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Syntactx
First posted: 2017-05-24
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with defined AAA who are elegible for surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful treatment
timeFrame: 1 year
Secondary outcomes:
measure: Treatment success
timeFrame: 1 month
measure: Treatment success
timeFrame: 2 years
measure: All-cause mortality
timeFrame: at 1 month, 1 year and at 2 years
measure: Major adverse events
timeFrame: at 1 month, 1 year and at 2 years
measure: Aneurysm related mortality
timeFrame: up to 30 days after index procedure or within 30 days after aneurysm-related reintervention
measure: Stent graft migration of >5mm (with 30 days measurement as baseline)
timeFrame: at 1 year and at 2 years
measure: Endoleak
timeFrame: at initial procedure, 1 month, 1 year and at 2 years
measure: Amount of secondary procedures to correct endoleaks
timeFrame: 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)
measure: Amount of secondary procedures for occlusion and/or kinking to restore stent graft function (endovascular and open procedures)
timeFrame: From the day after the initial procedure up to 2 years after the initail procedure which is the end of the follow up period
measure: Amount of secondary surgical interventions for stent graft infection
timeFrame: From the day after the initial procedure up to 2 years after the initail procedure which is the end of the follow up period
measure: Amount of major lower limb amputation
timeFrame: 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)
measure: Which kind of vascular access is used during surgical intervention
timeFrame: at the primary procedure
measure: Access site complications
timeFrame: during procedure up to 45 days
measure: Amount of secondary open surgical interventions
timeFrame: 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)
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Genk
country: Belgium
facility: Hospital Oost Limburg
city: Gent
country: Belgium
facility: University Hospital Gent
city: Frankfurt am Main
country: Germany
facility: Hospital Frankfurt Höchst
city: Hamburg
country: Germany
facility: University hospital Hamburg
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Nürnberg
country: Germany
facility: Hospital Nürnberg Süd
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord Brabant
city: Amsterdam
country: Netherlands
facility: VUmc
city: Den Haag
country: Netherlands
facility: HagaHospital
city: Maastricht
country: Netherlands
facility: MUMC+
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Philippe Cuypers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: