ZEnith AlPHa for AneurYsm Repair

Overview

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.

Full Title of Study: “ZEnith AlPHa for AneurYsm Repair (ZEPHYR)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2022

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

  • Procedure: Zenith Alpha Abdominal stentgraft

Arms, Groups and Cohorts

  • Patient with AAA
    • Patient will receive a ‘Zenith Alpha Abdominal stentgraft’ as intervention to eliminate the abdominal aortic aneurysm.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • All-cause mortality
    • Time Frame: at 1 month, 1 year and at 2 years
    • All-cause mortality
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Philippe Cuypers
  • Collaborator
    • Syntactx
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Philippe Cuypers, MD, PhD – Catharina Ziekenhuis Eindhoven
  • Overall Official(s)
    • Philippe Cuypers, MD, PhD, Principal Investigator, Catharina Ziekenhuis Eindhoven

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.