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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Herz-Zentrums Bad Krozingen
Sponsor:
Collaborator:
Heart Center Bad Krozingen
Information provided by (Responsible Party):
Aljoscha Rastan, Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:
NCT01398033
First received: July 19, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
In-stent Stenosis of Infrapopliteal Arteries
Device: paclitaxel-coated balloon
Device: non-coated balloon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis

Resource links provided by NLM:


Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • primary patency of target lesion assessed by quantitative angiography [ Time Frame: 3 months after index procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary patency of the target lesion assessed by quantitative angiography [ Time Frame: 12 months after index procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drug-coated balloon
  1. pre-dilatation of the target lesion with a non-coated balloon.
  2. 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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398033

Contacts
Contact: Aljoscha Rastan, M.D. 004976334024913 aljoscha.rastan@herzzentrum.de
Contact: Thomas Zeller, M.D. 004976334022430 thomas.zeller@herzzentrum.de

Locations
Germany
Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79219
Contact: Aljoscha Rastan, M.D.    004976334024913    aljoscha.rastan@herzzentrum.de   
Contact: Thomas Zeller, M.D.    004976334022430    thomas.zeller@herzzentrum.de   
Sponsors and Collaborators
Herz-Zentrums Bad Krozingen
Heart Center Bad Krozingen
Investigators
Principal Investigator: Aljoscha Rastan, M.D. Herzzentrum Bad Krozingen
  More Information

No publications provided

Responsible Party: Aljoscha Rastan, MD, Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier: NCT01398033     History of Changes
Other Study ID Numbers: FW-014-1
Study First Received: July 19, 2011
Last Updated: January 3, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Herz-Zentrums Bad Krozingen:
infrapopliteal arteries
In-stent stenosis
long lesions
drug-coated balloon

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014