In-stent Stenosis of Infrapopliteal Arteries Clinical Trial
— BAIROfficial title:
Paclitaxel-Coated Versus Uncoated Balloon for Treatment of Below-the-Knee In-Stent-Restenosis
| Verified date | August 2015 |
| Source | Herz-Zentrums Bad Krozingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Herzzentrum Bad Krozingen | Bad Krozingen |
| Lead Sponsor | Collaborator |
|---|---|
| Herz-Zentrums Bad Krozingen | Heart Center Bad Krozingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | primary patency of target lesion assessed by quantitative angiography | 3 months after index procedure | No | |
| Secondary | Secondary patency of the target lesion assessed by quantitative angiography | 12 months after index procedure | No |