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Peripheral Arterial DiseaseBATTLENCT02004951

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

A study testing Misago RX and Zilver PTX in people with Peripheral Arterial Disease and Femoropopliteal Lesions, run by Nantes University Hospital at 11 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Misago RX and Zilver PTX
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
11 sitesFrance
Study dates
25 Mar 2014to 7 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Asymptomatic lesion
  • Restenosis
  • No atheromatous disease
  • Untreated >50% DS of the inflow tract
  • Resting ankle brachial index (ABI) unavailable
  • Female of child bearing potential
Show all 22Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Clinique d'Antony

    Antony

  • CHU de Besançon

    Besançon

  • CHU de Bordeaux

    Bordeaux

  • Centre Hospitalier Pierre Oudot Bourgoin Jallieu

    Bourgoin, 38302

  • CHU de Clermont Ferrand

    Clermont-Ferrand

  • AP-HP, Hôpital Henri Mondor

    Créteil

  • CHU de Lyon

    Lyon

  • CHU Nantes

    Nantes, 44000

  • Clinique Ollioules

    Ollioules

  • CHU de Rennes

    Rennes

  • Clinique Pasteur

    Toulouse

Other trials in France

About this study

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).

Being tested
Misago RX, Zilver PTX
Keywords
Superficial femoral artery, paclitaxel, stent, self expandable, restenosis, endovascular, above-the-knee intermediate length
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Misago RXDevice

    Also called Treatment of above-the-knee intermediate length femoropopliteal lesions

  • Zilver PTXDevice

Study groups in NCT02004951
Study groupRoleWhat they receive
Misago RX (Misago RX, Terumo Corp., TokyoOtherThe 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.
Receives: Device: Misago RX
Zilver PTX (Cook Medical, Bloomington, IN, USA)OtherZilver 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.
Receives: Device: Zilver PTX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (13)

  1. residual diameter stenosis

    Technical success defined achievement of a final residual diameter stenosis of <30% on the procedural completion angiogram.

    Measured: Day 0

  2. 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.

    Measured: 1 month, 12 months and 24 months

  3. Secondary sustained clinical improvement

    primary sustained clinical improvement including the need for repeated TLR.

    Measured: 1 month, 12 months and 24 months

  4. Primary patency

    patency without any percutaneous or surgical intervention in the treated segment or in the adjacent areas.

    Measured: 1 month, 12 months and 24 months

  5. Major adverse events

    MACEs including all deaths, major amputation.

    Measured: 1 month, 12 months and 24 months

  6. Limb salvage

    freedom from major ipsilateral amputations

    Measured: 1 month, 12 months and 24 months

  7. Death

    Death (all cause)

    Measured: 1 month, 12 months and 24 months

  8. Ankle brachial index

    Ankle brachial index

    Measured: 1 month, 6 months, 12 months and 24 months

  9. 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.

    Measured: 1 month, 12 months and 24 months

  10. 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.

    Measured: 1 month, 12 months and 24 months

  11. Stent fracture

    Stent fractures were assessed by biplane x-rays

    Measured: 1 month, 12 months and 24 months

  12. 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

    Measured: 1 month, 12 months and 24 months

  13. Economic analysis objective

    Incremental cost-effectiveness ratio (ICER) based on quality of life for CUA and on freedom from in-stent restenosis for CEA

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study start25 Mar 2014
  3. Primary completion31 Aug 2017
  4. Study completion7 Aug 2020

Why it stopped: Batch recall for Misago Terumo self-expanding peripheral stent systems.(withdrawal from the market)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02004951
Sponsor's protocol ID
RC13_0290
Acronym
BATTLE
Status last verified
Feb 2021
First submitted
3 Dec 2013
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No

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.

    PubMed 25359394

Questions about this trial

What is this clinical trial studying?

A study testing Misago RX and Zilver PTX in people with Peripheral Arterial Disease and Femoropopliteal Lesions, run by Nantes University Hospital at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Batch recall for Misago Terumo self-expanding peripheral stent systems.(withdrawal from the market)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from in-stent restenosis at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02004951, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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