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

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ClinicalTrials.gov Identifier: NCT02004951
Recruitment Status : Unknown
Verified June 2017 by Nantes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Femoropopliteal Lesions Device: Misago RX Device: Zilver PTX Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
Actual Study Start Date : March 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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 Name: Treatment of above-the-knee intermediate length femoropopliteal lesions

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



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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004951


Locations
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France
Clinique d'Antony
Antony, France
CHU de Besançon
Besançon, France
CHU de Bordeaux
Bordeaux, France
Centre Hospitalier Pierre Oudot Bourgoin Jallieu
Bourgoin Jallieu, France, 38302
CHU de Clermont Ferrand
Clermont Ferrand, France
AP-HP, Hôpital Henri Mondor
Créteil, France
CHU de Lyon
Lyon, France
Clinique Ollioules
Ollioules, France
CHU de Rennes
Rennes, France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Chair: Yann GOUEFFIC, Professor Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02004951     History of Changes
Other Study ID Numbers: RC13_0290
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Nantes University Hospital:
Superficial femoral artery
paclitaxel
stent
self expandable
restenosis
endovascular
above-the-knee intermediate length

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action