Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery

Launched by KUOPIO UNIVERSITY HOSPITAL · Oct 11, 2011

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special type of stent called a Paclitaxel eluting stent compared to traditional bypass surgery in treating long blockages in the femoral artery, which can lead to severe leg pain and other complications. The trial aims to help patients with conditions like chronic lower limb ischemia, where blood flow to the legs is reduced, making it difficult to walk or causing pain. Researchers are looking to recruit around 400 patients, aged between 65 to 74, who have significant leg pain that limits their daily activities or those with critical ischemia, a more severe condition.

Eligible participants will need to have a specific type of blockage in their artery and should have tried conservative treatments first. Those interested in joining can expect to be randomly assigned to either receive the new stent or undergo bypass surgery, with follow-ups to assess the success of the treatment over two years. The study will also look at other important factors, like any complications that arise during treatment and how the procedures affect the patients' quality of life. This trial is important as it explores a potentially less invasive option for treating leg artery blockages, which could provide a safer alternative to surgery for many patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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