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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT01450722 |
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Date of registration:
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07/10/2011 |
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Primary sponsor: |
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Public title:
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Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery
finnptx |
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Scientific title:
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Paclitaxel Eluting Stent in Long Superficial Femoral Artery Obstruction: a Prospective, Randomized Comparison With Bypass Surgery Using PTFE Graft in a Finnish Multicenter Study |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01450722 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Finland
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Contacts
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Name:
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Pkks |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Hannu Manninen, professor |
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Address:
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Telephone:
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358-447113318 |
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Email:
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hannu.manninen@kuh.fi |
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Affiliation:
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Name:
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Hannu I Manninen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kuopio University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Lower Limb Ischemia
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Claudication
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Critical Ischemia
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Peripheral Athero Obstructive Disease
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Intervention(s)
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Procedure: bypass surgery, stent placement
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Procedure: stent placement
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Primary Outcome(s)
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Primary patency of the stent or graft at two year follow up
[Time Frame: Ultrasound study at 2 years]
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Secondary Outcome(s)
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Amputation free survival
[Time Frame: 2 years]
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Secondary ID(s)
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KUH5063524
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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