Status:
WITHDRAWN
Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
Lead Sponsor:
Herz-Zentrums Bad Krozingen
Collaborating Sponsors:
University Heart Center Freiburg - Bad Krozingen
Conditions:
In-stent Stenosis of Infrapopliteal Arteries
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01398033
Start Date
April 1 2012
End Date
September 1 2014
Last Update
August 5 2015
Active Locations (1)
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1
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79219