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

Primary Purpose

In-stent Stenosis of Infrapopliteal Arteries

Status

Withdrawn

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

paclitaxel-coated balloon

non-coated balloon

About this trial

This is an interventional treatment trial for In-stent Stenosis of Infrapopliteal Arteries focused on measuring infrapopliteal arteries, In-stent stenosis, long lesions, drug-coated balloon

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Herzzentrum Bad Krozingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drug-coated balloon

non-coated balloon

Arm Description

pre-dilatation of the target lesion with a non-coated balloon. treatment of the target lesion with the paclitaxel-coated balloon

Treatment of the target lesion with plain balloon angioplasty.

Outcomes

Primary Outcome Measures

primary patency of target lesion assessed by quantitative angiography

Secondary Outcome Measures

Secondary patency of the target lesion assessed by quantitative angiography

Full Information

NCT ID

NCT01398033

First Posted

July 19, 2011

Last Updated

August 3, 2015

Sponsor

Herz-Zentrums Bad Krozingen

Collaborators

University Heart Center Freiburg - Bad Krozingen

1. Study Identification

Unique Protocol Identification Number

NCT01398033

Brief Title

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

Acronym

BAIR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Study stopped due to lack of patient inclusion

Study Start Date

April 2012 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herz-Zentrums Bad Krozingen

Collaborators

University Heart Center Freiburg - Bad Krozingen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

In-stent Stenosis of Infrapopliteal Arteries

Keywords

infrapopliteal arteries, In-stent stenosis, long lesions, drug-coated balloon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug-coated balloon

Arm Type

Active Comparator

Arm Description

pre-dilatation of the target lesion with a non-coated balloon. treatment of the target lesion with the paclitaxel-coated balloon

Arm Title

non-coated balloon

Arm Type

Placebo Comparator

Arm Description

Treatment of the target lesion with plain balloon angioplasty.

Intervention Type

Device

Intervention Name(s)

paclitaxel-coated balloon

Intervention Description

Balloon is coated with paclitaxel in a concentration of 3µg/mm2.

Intervention Type

Device

Intervention Name(s)

non-coated balloon

Intervention Description

percutaneous transluminal angioplasty with a non-coated balloon

Primary Outcome Measure Information:

Title

primary patency of target lesion assessed by quantitative angiography

Time Frame

3 months after index procedure

Secondary Outcome Measure Information:

Title

Secondary patency of the target lesion assessed by quantitative angiography

Time Frame

12 months after index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aljoscha Rastan, M.D.

Organizational Affiliation

Herzzentrum Bad Krozingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herzzentrum Bad Krozingen

City

Bad Krozingen

ZIP/Postal Code

79219

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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