BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting… (NCT02004951) | Clinical Trial Compass
TerminatedNot Applicable
BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Stopped: Batch recall for Misago Terumo self-expanding peripheral stent systems.(withdrawal from the market)
France186 participantsStarted 2014-03-25
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Patient ≥18 years
* Patient has a history of symptomatic peripheral arterial disease (Rutherford classification: 2-5)
* Lesion is eligible for treatment with a maximum of 2 stents per lesion (treatment of both legs is not permitted)
* Patient is affiliated to the Social Security or equivalent system
* Patient has been informed of the nature of the study, agrees to its provisions (and only for swiss centers, has signed the informed consent form prior to any study related procedure)
* Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
* Reference vessel diameter 4 to 7-mm determined by CT scan (RVD obtained from averaging 5-mm segments proximal and distal to the lesions)
* Target lesion has a pre-procedure percent diameter stenosis of ≥ 50% DS
* De novo atherosclerotic lesions (stenosis and/or occlusion) of the superficial femoral artery, the proximal popliteal artery (P1), or both. The treatment area in the SFA and popliteal artery extended from 1 cm below the origin of the profunda femoris artery to 3 cm above the proximal margin of the intercondylar fossa of the femur.
* Target lesion (single or multiple) has a maximal total length =14-cm and a minimal length = 2-cm
* At least 1 patent runoff vessel (\<50% DS throughout its course). The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon.
Exclusion Criteria
* Asymptomatic lesion
* Restenosis
* No athero…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.