BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions (BATTLE)
|ClinicalTrials.gov Identifier: NCT02004951|
Recruitment Status : Unknown
Verified June 2017 by Nantes University Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : June 8, 2017
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1 Enlargement of endovascular therapy indication was based on patient choice for a less invasive technique and evidence based medicine. Consequently, TASC classification of lesions has been modified to reflect increased evidence for endovascular treatment of more extensive femoropopliteal lesions, and indication for endovascular repair has been enlarged to more severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the interventionalists have at their disposal a huge tool box. Evaluation of these tools is crucial to determine the right treatment strategy to avoid further reinterventions and overcosts.
The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee intermediate length femoropopliteal lesions.
From hospitals in Europe (France, Switzerland) we will randomly assign patients with symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Femoropopliteal Lesions||Device: Misago RX Device: Zilver PTX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions|
|Actual Study Start Date :||March 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2018|
Misago RX (Misago RX, Terumo Corp., Tokyo
The Misago RX is a peripheral stent (Misago RX, Terumo Corp., Tokyo, Japan) indicated to treat iliac and femoropopliteal arteries. The Misago RX is a flexible self-expanding nitinol stent that is delivered via a RX monorail delivery catheter.
Device: Misago RX
Other Name: Treatment of above-the-knee intermediate length femoropopliteal lesions
Zilver PTX (Cook Medical, Bloomington, IN, USA)
Zilver PTX (Cook Medical, Bloomington, IN, USA) is a nitinol stent with a polymer-free paclitaxel coating designed to treat the above- the-knee femoropopliteal arteries. The anti-proliferative drug is the paclitaxel, a cytotoxic drug. The Zilver PTX stent is delivered via a over-the-wire system.
Device: Zilver PTX
- Freedom from in-stent restenosis at 1 year [ Time Frame: 1 year ]It was defined by restenosis of >50% and by a peak systolic velocity index >2.4 at the target lesion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004951
|CHU de Besançon|
|CHU de Bordeaux|
|Centre Hospitalier Pierre Oudot Bourgoin Jallieu|
|Bourgoin Jallieu, France, 38302|
|CHU de Clermont Ferrand|
|Clermont Ferrand, France|
|AP-HP, Hôpital Henri Mondor|
|CHU de Lyon|
|CHU de Rennes|
|Study Chair:||Yann GOUEFFIC, Professor||Nantes University Hospital|