ZEnith AlPHa for AneurYsm Repair (ZEPHYR)

July 19, 2022 updated by: Philippe Cuypers

ZEnith AlPHa for AneurYsm Repair (ZEPHYR)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
354

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Imelda Hospital
      • Genk, Belgium
        • Hospital Oost Limburg
      • Gent, Belgium
        • University Hospital Gent
  • Germany
      • Frankfurt am Main, Germany
        • Hospital Frankfurt Höchst
      • Hamburg, Germany
        • University Hospital Hamburg
      • Heidelberg, Germany
        • University Hospital Heidelberg
      • Nürnberg, Germany
        • Hospital Nürnberg Süd
  • Netherlands
      • Amsterdam, Netherlands
        • VUmc
      • Den Haag, Netherlands
        • Hagahospital
      • Maastricht, Netherlands
        • MUMC+
      • Rotterdam, Netherlands
        • Maasstad Hospital
    • Noord Brabant
      • Eindhoven, Noord Brabant, Netherlands, 5623EJ
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with defined AAA who are elegible for surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient with AAA
Patient will receive a 'Zenith Alpha Abdominal stentgraft' as intervention to eliminate the abdominal aortic aneurysm.
Procedure: Zenith Alpha Abdominal stentgraft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successful treatment
Time Frame: 1 year
Proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: 1 month
Proportion of subjects who experience successful treatment at 1 month post-implant; defined by technical success and clinical success.
1 month
Treatment success
Time Frame: 2 years
Proportion of subjects who experience successful treatment at 2 years post-implant; defined by technical success and clinical success.
2 years
All-cause mortality
Time Frame: at 1 month, 1 year and at 2 years
All-cause mortality
at 1 month, 1 year and at 2 years
Major adverse events
Time Frame: 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
at 1 month, 1 year and at 2 years
Aneurysm related mortality
Time Frame: 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
up to 30 days after index procedure or within 30 days after aneurysm-related reintervention
Stent graft migration of >5mm (with 30 days measurement as baseline)
Time Frame: at 1 year and at 2 years
Stent graft migration of >5mm (with 30 days measurement as baseline)
at 1 year and at 2 years
Endoleak
Time Frame: at initial procedure, 1 month, 1 year and at 2 years
Any type of endoleak; tabulated by type (Ia, Ib, II or III)
at initial procedure, 1 month, 1 year and at 2 years
Amount of secondary procedures to correct endoleaks
Time Frame: 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
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 secondary procedures for occlusion and/or kinking to restore stent graft function (endovascular and open procedures)
Time Frame: 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)
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 interventions for stent graft infection
Time Frame: 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
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 major lower limb amputation
Time Frame: 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
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)
Which kind of vascular access is used during surgical intervention
Time Frame: at the primary procedure
Vascular access can either be unilateral, bilateral, open access or percutaneus access
at the primary procedure
Access site complications
Time Frame: during procedure up to 45 days
Hematoma, false aneurysm, vessel injury, primary conversion to femoral cutdown, surgical reintervention postoperative, false aneurysm at puncture site
during procedure up to 45 days
Amount of secondary open surgical interventions
Time Frame: 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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philippe Cuypers

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syntactx

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Cuypers, MD, PhD, Catharina Ziekenhuis Eindhoven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZEPHYR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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