ZEnith AlPHa for AneurYsm Repair

Aneurysm Clinical Trial

— ZEPHYR  

Official title:

ZEnith AlPHa for AneurYsm Repair (ZEPHYR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165279
• Other study ID #: ZEPHYR
• Status: Completed
• Start date: December 7, 2016
• Est. completion date: July 2022

Study information

• Verified date: July 2022
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: July 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm

Intervention

Procedure:
• Zenith Alpha Abdominal stentgraft

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	Hospital Oost Limburg	Genk
Belgium	University Hospital Gent	Gent
Germany	Hospital Frankfurt Höchst	Frankfurt am Main
Germany	University hospital Hamburg	Hamburg
Germany	University Hospital Heidelberg	Heidelberg
Germany	Hospital Nürnberg Süd	Nürnberg
Netherlands	VUmc	Amsterdam
Netherlands	HagaHospital	Den Haag
Netherlands	Catharina Hospital	Eindhoven	Noord Brabant
Netherlands	MUMC+	Maastricht
Netherlands	Maasstad Hospital	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Philippe Cuypers	Syntactx

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful treatment	Proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.	1 year
Secondary	Treatment success	Proportion of subjects who experience successful treatment at 1 month post-implant; defined by technical success and clinical success.	1 month
Secondary	Treatment success	Proportion of subjects who experience successful treatment at 2 years post-implant; defined by technical success and clinical success.	2 years
Secondary	All-cause mortality	All-cause mortality	at 1 month, 1 year and at 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Endoleak	Any type of endoleak; tabulated by type (Ia, Ib, II or III)	at initial procedure, 1 month, 1 year and at 2 years
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)