Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01398033
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT01398033
Study Brief:
Protocol Section:
NCT01398033