BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
- Conditions
- Peripheral Arterial DiseaseFemoropopliteal Lesions
- Interventions
- Device: Misago RXDevice: Zilver PTX
- Registration Number
- NCT02004951
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 186
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misago RX (Misago RX, Terumo Corp., Tokyo Misago RX 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. Zilver PTX (Cook Medical, Bloomington, IN, USA) Zilver PTX 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.
- Primary Outcome Measures
Name Time Method Freedom from in-stent restenosis at 1 year 1 year It was defined by restenosis of \>50% and by a peak systolic velocity index \>2.4 at the target lesion.
- Secondary Outcome Measures
Name Time Method residual diameter stenosis Day 0 Technical success defined achievement of a final residual diameter stenosis of \<30% on the procedural completion angiogram.
Primary sustained clinical improvement 1 month, 12 months and 24 months sustained upward shift of _1 category of the Rutherford classification for claudicants and by wound healing and rest pain resolution for patients in CLI, without the need for repeated TLR in surviving patients.
Secondary sustained clinical improvement 1 month, 12 months and 24 months primary sustained clinical improvement including the need for repeated TLR.
Primary patency 1 month, 12 months and 24 months patency without any percutaneous or surgical intervention in the treated segment or in the adjacent areas.
Major adverse events 1 month, 12 months and 24 months MACEs including all deaths, major amputation.
Limb salvage 1 month, 12 months and 24 months freedom from major ipsilateral amputations
Death 1 month, 12 months and 24 months Death (all cause)
Ankle brachial index 1 month, 6 months, 12 months and 24 months Ankle brachial index
Target Extremity Revascularization (TER) 1 month, 12 months and 24 months TER is defined as any percutaneous intervention or surgical bypass of any segment of the target extremity. The target extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Target lesion revascularization (TLR) 1 month, 12 months and 24 months TLR expresses the frequency of the need for repeated procedures (endovascular or surgical) due to a problem arising from the stent (1 cm proximally and distally to include edge phenomena) in surviving patients with preserved limb.
Stent fracture 1 month, 12 months and 24 months Stent fractures were assessed by biplane x-rays
EQ-5D-3L questionnaire 1 month, 12 months and 24 months Quality of life - EQ-5D-3L questionnaire EQ-5D-3L = European Quality of Life 5 Dimensions and 3 Lines Scale from 0 to 100. 0 =Worst imaginable state of health 100= Best imaginable state of health
Economic analysis objective 2 years Incremental cost-effectiveness ratio (ICER) based on quality of life for CUA and on freedom from in-stent restenosis for CEA
Trial Locations
- Locations (11)
Clinique Ollioules
🇫🇷Ollioules, France
Clinique Pasteur
🇫🇷Toulouse, France
CHU de Bordeaux
🇫🇷Bordeaux, France
Centre Hospitalier Pierre Oudot Bourgoin Jallieu
🇫🇷Bourgoin Jallieu, France
CHU de Clermont Ferrand
🇫🇷Clermont Ferrand, France
AP-HP, Hôpital Henri Mondor
🇫🇷Créteil, France
CHU de Lyon
🇫🇷Lyon, France
Clinique d'Antony
🇫🇷Antony, France
CHU de Besançon
🇫🇷Besançon, France
CHU Nantes
🇫🇷Nantes, France
CHU de Rennes
🇫🇷Rennes, France