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

NCT01398033 | Withdrawn Phase 3 DMC

• 1 other identifier: FW-014-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

In-stent Stenosis of Infrapopliteal Arteries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• primary patency of target lesion assessed by quantitative angiography

  3 months after index procedure

Secondary Outcomes (1)

• Secondary patency of the target lesion assessed by quantitative angiography

  12 months after index procedure

Study Arms (2)

Drug-coated balloon

ACTIVE COMPARATOR

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

non-coated balloon

PLACEBO COMPARATOR

Treatment of the target lesion with plain balloon angioplasty.

Device: non-coated balloon

Interventions

paclitaxel-coated balloon DEVICE

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

Drug-coated balloon

non-coated balloon DEVICE

percutaneous transluminal angioplasty with a non-coated balloon

non-coated balloon

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herz-Zentrums Bad Krozingen: lead
• University Heart Center Freiburg - Bad Krozingen: collaborator

Study Sites (1)

Herzzentrum Bad Krozingen

Bad Krozingen, 79219, Germany

Location

Study Officials

• Aljoscha Rastan, M.D.

  Herzzentrum Bad Krozingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 20, 2011
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

DE (1)