Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis (BAIR)

There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb. To date only a small number of these patients could be helped through medication or surgery. The indications for stent placement are poor primary results following percutaneous transluminal angioplasty or evidence of a flow-limiting dissection. The primary success rate after a stent placement is between 80% and 90%. One so far inconsistent discussed problem is the occurrence of in-stent restenosis which is expected in 20% to 78% of treated lesions, depending on the stent used. Using only percutaneous transluminal angioplasty for treatment of an in-stent restenosis, restenosis reoccurs in 70% to 80% of cases.

The aim of this study is to analyse the primary success and the long term results of angioplasty using the drug-coated balloon (paclitaxel) compared to an non-coated balloon in the treatment of in-stent restenosis of lower limb arteries.

Study Overview

• Status: Withdrawn
• Conditions: In-stent Stenosis of Infrapopliteal Arteries
• Intervention / Treatment: Device: paclitaxel-coated balloon; Device: non-coated balloon

Detailed Description

In this prospective, double-blind, randomised, multi-centre study the use of the already certified coated balloon and an uncoated balloon is evaluated in patients with in-stent restenoses/reocclusions of the lower limb artery. The whole lesion length should be covered by the balloon so that proximal and distal overlap of the lesion by a minimum of 5mm is assured. Based on the current literature the average restenoses rate of the lower limb arteries after percutaneous transluminal angioplasty of an in-stent restenosis is 70% after 6 months. Assuming the restenosis rate reduces to 30% after percutaneous transluminal angioplasty using a drug-coated balloon, with a significance level of Alpha=0.05 (bilateral) and a power Beta=0.8, the enrolment of 100 patients is required in order to show a significant difference between treatment groups, considering a dropout rate of 30%. The choice of treatment will be distributed in a randomised, double blind procedure.

The study duration per patient is 2 years. Clinical follow-up evaluations will take place after 3 and 6 months and after 1 and 2 years. After 3 month and 12 months an angiography of the target vessel will be performed.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79219
    • Herzzentrum Bad Krozingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 50 years
• Signed declaration of consent
• Subject is willing and able to participate in all the planned evaluations of the study protocol
• Arterial occlusion disease stage 3 - 6 Rutherford-Becker
• Subject with an in-stent stenosis over 70% of the vascular lumen diameter of the tibioperoneal trunc and/or the posterior tibial artery and/or of the anterior tibial artery and/or peroneal artery. Here vascular segments, which are affected continuous (including stent), proximal or distal of the stent by a relevant (re)stenosis, are treated according to randomisation
• The length of the target lesion(s) should not exceed 290mm
• In total four drug-coated balloons are enough to treat a maximum of two lesions
• The target lesion's lumen diameter is between 2.0mm and 3.5mm
• Successful passage of the wire to the target lesion before randomisation

Exclusion Criteria:

• Coagulopathy
• Pregnancy
• Contraindications for antiplatelet or heparin
• Factors which exclude a follow up
• Life expectancy <12 months
• Known allergies to contrast agents and/or Clopidogrel and/or Aspirin
• >50% stenosis distal of the target lesion
• Visible thrombus in the target lesion
• Lytic therapy 72 hours before the planned intervention
• Aneurysm of the femoral or popliteal artery
• Intervention of focal lesions of the femoral or popliteal artery may be carried out before treatment of the target lesion in order to enhance the inflow in the lower limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug-coated balloon; pre-dilatation of the target lesion with a non-coated balloon.; treatment of the target lesion with the paclitaxel-coated balloon	Device: paclitaxel-coated balloon; Balloon is coated with paclitaxel in a concentration of 3µg/mm2.
Placebo Comparator: non-coated balloon; Treatment of the target lesion with plain balloon angioplasty.	Device: non-coated balloon; percutaneous transluminal angioplasty with a non-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
primary patency of target lesion assessed by quantitative angiography	3 months after index procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary patency of the target lesion assessed by quantitative angiography	12 months after index procedure

Collaborators and Investigators

• Sponsor: Herz-Zentrums Bad Krozingen
• Collaborators: University Heart Center Freiburg - Bad Krozingen
• Investigators: Principal Investigator: Aljoscha Rastan, M.D., Herzzentrum Bad Krozingen

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: drug-coated balloon; In-stent stenosis; long lesions; infrapopliteal arteries
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: FW-014-1