4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease (4-EVER)
The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.
The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).
|Peripheral Vascular Disease Claudication||Device: 4F portfolio products from Biotronik||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease|
- Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention [ Time Frame: 12 months ]Primary patency at 12 months, defined as freedom from >50% restenosis
- Technical success [ Time Frame: 1 day post-procedure ]Technical success, defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.
- Puncture site complications [ Time Frame: 10 days ]Number of puncture site complications in the absence of a closure device after intervention
- Primary patency [ Time Frame: 6- & 24-month follow-up ]Primary patency rate at 6- & 24-month follow-up, defined as freedom from >50% restenosis at 6 & 24 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention.
- Clinical success [ Time Frame: 6-, 12- & 24-month follow-up ]Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12- & 24-month follow-up of one class or more as compared to the pre-procedure
- Stent fracture rate at 12- & 24-month follow-up [ Time Frame: 12- & 24-month follow-up ]
Stent fracture rate at 12- & 24-month follow-up (in patient who were treated with stentplacement), as determined according the following classification on x-ray:
- Class 0 : no strut factures
- Class I : single tine fracture
- Class II : multiple tine factures
- Class III : Stent fracture(s) with preserved alignment of the components
- Class IV : Stent fracture(s) with mal-alignment of the components
- Class V : Stent fracture(s) in a trans-axial spiral configuration
|Study Start Date:||July 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
4F portfolio products from Biotronik
The devices under investigation are the 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18 and Cruiser-18.
Device: 4F portfolio products from Biotronik
4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413139
|Bonheiden, Antwerpen, Belgium, 2820|
|Universitair ziekenhuis antwerpen|
|Edegem, Antwerpen, Belgium, 2650|
|AZ Sint Blasius|
|Dendermonde, Oost-Vlaanderen, Belgium, 9200|
|Leipzig, Germany, 04289|
|St Fransiskus hospital|
|Münster, Germany, 48145|
|Principal Investigator:||Marc Bosiers, MD||AZ Sint Blasius, Dendermonde, Belgium|