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

NCT02004951 | Terminated

• 1 other identifier: RC13_0290
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 11

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).

Conditions

Peripheral Arterial Disease; Femoropopliteal Lesions

Keywords

Superficial femoral artery; paclitaxel; stent; self expandable; restenosis; endovascular; above-the-knee intermediate length

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (13)

• residual diameter stenosis

  Day 0

• Primary sustained clinical improvement

  1 month, 12 months and 24 months

• Secondary sustained clinical improvement

  1 month, 12 months and 24 months

• Primary patency

  1 month, 12 months and 24 months

• Major adverse events

  1 month, 12 months and 24 months

Study Arms (2)

Misago RX (Misago RX, Terumo Corp., Tokyo

OTHER

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

Zilver PTX (Cook Medical, Bloomington, IN, USA)

OTHER

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

Interventions

Misago RX DEVICE

Also known as: Treatment of above-the-knee intermediate length femoropopliteal lesions

Misago RX (Misago RX, Terumo Corp., Tokyo

Zilver PTX DEVICE

Zilver PTX (Cook Medical, Bloomington, IN, USA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (11)

Clinique d'Antony

Antony, France

Location

CHU de Besançon

Besançon, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Centre Hospitalier Pierre Oudot Bourgoin Jallieu

Bourgoin, 38302, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, France

Location

AP-HP, Hôpital Henri Mondor

Créteil, France

Location

CHU de Lyon

Lyon, France

Location

CHU Nantes

Nantes, 44000, France

Location

Clinique Ollioules

Ollioules, France

Location

CHU de Rennes

Rennes, France

Location

Clinique Pasteur

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 25359394 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Yann GOUEFFIC, Professor

  Nantes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: March 25, 2014
• Primary Completion: August 31, 2017
• Study Completion: August 7, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

FR (11)