Claudication Clinical Trial
— finnptxOfficial title:
Paclitaxel Eluting Stent in Long Superficial Femoral Artery Obstruction: a Prospective, Randomized Comparison With Bypass Surgery Using PTFE Graft in a Finnish Multicenter Study
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%. The prevalence of its milder symptomatic manifestation, intermittent claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about 10% of the patients the ischemia worsens to threat the vitality of the limb. Although intermittent claudication has a benign prognosis and can often treated conservatively, more severe forms with extensive arterial obstructions require revascularization, either open surgical or endovascular. Surgical bypass operations are currently the standard reference for treating long femoral artery obstructions. Surgical bypass operations are accompanied by significant acute complications and late adverse effects, especially in patients with associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and effective endovascular therapies are seeked for. The long term patency rates of infrainguinal balloon angioplasty (PTA) vary largely in different studies but they are mostly poor when long femoral arterial obstructions have been treated. Drug eluting stents have shown great promise in coronary artery interventions. The purpose of this study is to compare Paclitaxel eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using PTFE graft to proximal popliteal artery in the treatment of long femoral artery obstructions (total length of 10-25 cm) in a prospective, randomized, Finnish multi center trial with consecutive claudicant and chronic critical ischemia patients. The aim is to randomize altogether 400 patients during about two years in five universities and in 2-3 central hospitals. The primary end point is patency at 24 month follow up. Secondary end points are primary success at patient discharge, complications, 30-day mortality, target lesion revascularization, quality of life, and economical analysis.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Kuopio University Hospital | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital | Finnish Society of Interventional radiology, Helsinki University Central Hospital, North Karelia Central Hospital, Oulu University Hospital, Paijat-Hame Hospital District, Tampere University Hospital, Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency of the stent or graft at two year follow up | Ultrasound study at 2 years | ||
Secondary | Amputation free survival | 2 years |
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