Clinical trial NCT02004951: BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Official title: BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Femoropopliteal Lesions
Keywords: Superficial femoral artery
paclitaxel
stent
self expandable
restenosis
endovascular
above-the-knee intermediate length
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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 atheromatous disease
* Untreated \>50% DS of the inflow tract
* Resting ankle brachial index (ABI) unavailable
* Female of child bearing potential
* Patient has received, or is on the waiting list for a major organ transplant
* Patient has a history of coagulopathy or will refuse blood transfusions
* Patient is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
* Severe concomitant disease with life expectation \< one year
* Known allergy to paclitaxel
* Contraindication to Aspirin or Clopidogrel and Ticlopidin (the patient must be able to receive Dual Anti-Platelet Treatment for 2 months after the procedure)
* Patient has an infected wound or osteomyelitis on the ipsilateral extremity or foot.
* Patient has had prior major amputation to the ipsilateral (target) extremity
* Patient is not able to give informed consent (and only for swiss centers)
* Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
* Patient has previously had, or requires, bypass surgery, endarterectomy or other vascular surgery on any vessel of the ipsilateral extremity
* In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
* Target lesion lies within or adjacent to an aneurysm
* Patient with an allergy to contrast agent
* Patient with a severe allergy to metal
* Surgery or endovascular intervention of the target member within 14 days preceding the BATTLE procedure

Primary outcomes:
measure: Freedom from in-stent restenosis at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: residual diameter stenosis
timeFrame: Day 0
measure: Primary sustained clinical improvement
timeFrame: 1 month, 12 months and 24 months
measure: Secondary sustained clinical improvement
timeFrame: 1 month, 12 months and 24 months
measure: Primary patency
timeFrame: 1 month, 12 months and 24 months
measure: Major adverse events
timeFrame: 1 month, 12 months and 24 months
measure: Limb salvage
timeFrame: 1 month, 12 months and 24 months
measure: Death
timeFrame: 1 month, 12 months and 24 months
measure: Ankle brachial index
timeFrame: 1 month, 6 months, 12 months and 24 months
measure: Target Extremity Revascularization (TER)
timeFrame: 1 month, 12 months and 24 months
measure: Target lesion revascularization (TLR)
timeFrame: 1 month, 12 months and 24 months
measure: Stent fracture
timeFrame: 1 month, 12 months and 24 months
measure: EQ-5D-3L questionnaire
timeFrame: 1 month, 12 months and 24 months
measure: Economic analysis objective
timeFrame: 2 years
Other outcomes:
Locations:
city: Antony
country: France
facility: Clinique d'Antony
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bourgoin Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot Bourgoin Jallieu
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand
city: Créteil
country: France
facility: AP-HP, Hôpital Henri Mondor
city: Lyon
country: France
facility: CHU de Lyon
city: Nantes
country: France
facility: CHU Nantes
city: Ollioules
country: France
facility: Clinique Ollioules
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Nantes University Hospital
name: Yann GOUEFFIC, Professor
role: STUDY_CHAIR
References:
citation: Goueffic Y, Kaladji A, Guyomarch B, Montagne C, Fairier D, Gestin S, Riche VP, Vent PA, Chaillou P, Costargent A, Patra P. Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial. Trials. 2014 Oct 30;15:423. doi: 10.1186/1745-6215-15-423.