4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease (4-EVER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01413139|
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : October 1, 2013
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%).
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease Claudication||Device: 4F portfolio products from Biotronik||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||September 2013|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|