NCT03165279

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

5.4 years

First QC Date

May 16, 2017

Last Update Submit

July 19, 2022

Conditions

Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Successful treatment

    Proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.

    1 year

Secondary Outcomes (14)

  • Treatment success

    1 month

  • Treatment success

    2 years

  • All-cause mortality

    at 1 month, 1 year and at 2 years

  • Major adverse events

    at 1 month, 1 year and at 2 years

  • Aneurysm related mortality

    up to 30 days after index procedure or within 30 days after aneurysm-related reintervention

  • +9 more secondary outcomes

Study Arms (1)

Patient with AAA

Patient will receive a 'Zenith Alpha Abdominal stentgraft' as intervention to eliminate the abdominal aortic aneurysm.

Procedure: Zenith Alpha Abdominal stentgraft

Interventions

Zenith Alpha Abdominal stentgraftPROCEDURE
Patient with AAA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with defined AAA who are elegible for surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Imelda Hospital

Bonheiden, Belgium

Location

Hospital Oost Limburg

Genk, Belgium

Location

University Hospital Gent

Ghent, Belgium

Location

Hospital Frankfurt Höchst

Frankfurt am Main, Germany

Location

University hospital Hamburg

Hamburg, Germany

Location

University Hospital Heidelberg

Heidelberg, Germany

Location

Hospital Nürnberg Süd

Nuremberg, Germany

Location

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

VUmc

Amsterdam, Netherlands

Location

MUMC+

Maastricht, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

HagaHospital

The Hague, Netherlands

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Philippe Cuypers, MD, PhD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 24, 2017

Study Start

December 7, 2016

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)BE(3)NL(5)