BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions (BATTLE)

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).

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease; Femoropopliteal Lesions
• Intervention / Treatment: Device: Zilver PTX; Device: Misago RX

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Antony, France
    • Clinique d'Antony
  • Besançon, France
    • CHU de Besançon
  • Bordeaux, France
    • CHU de Bordeaux
  • Bourgoin Jallieu, France, 38302
    • Centre Hospitalier Pierre Oudot Bourgoin Jallieu
  • Clermont Ferrand, France
    • CHU de Clermont Ferrand
  • Créteil, France
    • AP-HP, Hôpital Henri Mondor
  • Lyon, France
    • CHU de Lyon
  • Nantes, France, 44000
    • Chu Nantes
  • Ollioules, France
    • Clinique Ollioules
  • Rennes, France
    • CHU de Rennes
  • Toulouse, France
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Treatment of above-the-knee intermediate length femoropopliteal lesions
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from in-stent restenosis at 1 year	It was defined by restenosis of >50% and by a peak systolic velocity index >2.4 at the target lesion.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
residual diameter stenosis	Technical success defined achievement of a final residual diameter stenosis of <30% on the procedural completion angiogram.	Day 0
Primary sustained clinical improvement	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.	1 month, 12 months and 24 months
Secondary sustained clinical improvement	primary sustained clinical improvement including the need for repeated TLR.	1 month, 12 months and 24 months
Primary patency	patency without any percutaneous or surgical intervention in the treated segment or in the adjacent areas.	1 month, 12 months and 24 months
Major adverse events	MACEs including all deaths, major amputation.	1 month, 12 months and 24 months
Limb salvage	freedom from major ipsilateral amputations	1 month, 12 months and 24 months
Death	Death (all cause)	1 month, 12 months and 24 months
Ankle brachial index	Ankle brachial index	1 month, 6 months, 12 months and 24 months
Target Extremity Revascularization (TER)	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.	1 month, 12 months and 24 months
Target lesion revascularization (TLR)	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.	1 month, 12 months and 24 months
Stent fracture	Stent fractures were assessed by biplane x-rays	1 month, 12 months and 24 months
EQ-5D-3L questionnaire	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	1 month, 12 months and 24 months
Economic analysis objective	Incremental cost-effectiveness ratio (ICER) based on quality of life for CUA and on freedom from in-stent restenosis for CEA	2 years

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Study Chair: Yann GOUEFFIC, Professor, Nantes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2014
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 7, 2020

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: paclitaxel; stent; endovascular; restenosis; Superficial femoral artery; self expandable; above-the-knee intermediate length
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: RC13_0290