ZEnith AlPHa for AneurYsm Repair (ZEPHYR)

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: Completed
• Conditions: Aneurysm
• Intervention / Treatment: Procedure: Zenith Alpha Abdominal stentgraft

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: Observational
• Enrollment (Actual): 354

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Successful treatment	Proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	Proportion of subjects who experience successful treatment at 1 month post-implant; defined by technical success and clinical success.	1 month
Treatment success	Proportion of subjects who experience successful treatment at 2 years post-implant; defined by technical success and clinical success.	2 years
All-cause mortality	All-cause mortality	at 1 month, 1 year and at 2 years
Major adverse events	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	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)	Stent graft migration of >5mm (with 30 days measurement as baseline)	at 1 year and at 2 years
Endoleak	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	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)	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	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	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	Vascular access can either be unilateral, bilateral, open access or percutaneus access	at the primary procedure
Access site complications	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	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

• Sponsor: Philippe Cuypers
• Collaborators: Syntactx
• Investigators: Principal Investigator: Philippe Cuypers, MD, PhD, Catharina Ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2016
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID 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