Status:
RECRUITING
Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery
Lead Sponsor:
Kuopio University Hospital
Collaborating Sponsors:
Helsinki University Central Hospital
Turku University Hospital
Conditions:
Chronic Lower Limb Ischemia
Peripheral Athero Obstructive Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74 old is 4-22%. T...
Detailed Description
BACKGROUND Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74 old ...
Eligibility Criteria
Inclusion
- Patients suffering from severe life-style limiting claudication indicating revascularization as well as patients suffering from chronic critical ischemia and having de-novo SFA obstruction with total length of 7-20 cm will be recruited.
- For claudicant patients an attempt of conservative treatment should be attempted before revacularization therapy. Both surgical bypass operation and endovascular treatment should be able to be safely performed;
- the patient has not extensive additional cardio-pulmonary and/or cerebro-vascular diseases increasing remarkably operative risk.
- At least one patent artery is to the ankle level.
- The patient has given his/her informed consent.
- Previous or simultaneus endovascular therapy of coexisting iliac disease is not a contraindication but study groups should be balanced.
- Unplanned common femoral artery endarterectomy is not a contraindication when it is done at the same intervention to facilitate anastomosis creation.
Exclusion
- Patients who have not given their written informed consent.
- Patient has allergy for iodine contrast agent.
- Patient is undergoing hemodialysis.
- Patient has undergone previous endovascular treatment for the target lesion (restenotic lesions).
- Patient has also infrapopliteal disease indicating revascularization.
- Patient is pregnant
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01450722
Start Date
October 1 2011
End Date
December 31 2024
Last Update
March 7 2024
Active Locations (1)
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1
Kuopio University Hospital
Kuopio, Finland