ISRCTN74370657
Completed
Not Applicable
Prospective, multicentre, randomised double blinded evaluation of external beam radiation to prevent restenosis after femoropopliteal stenting to treat atherosclerotic stenosis or occlusion of femoropopliteal arteries
Hôtel-Dieu de Montréal (Canada)0 sites214 target enrollmentFebruary 24, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral vascular disease/femoropopliteal artery obstruction
- Sponsor
- Hôtel-Dieu de Montréal (Canada)
- Enrollment
- 214
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 16/07/2008:
- •1\. 45 years and older, either sex
- •2\. Femoropopliteal lesion greater than 4 cm above knee joint
- •3\. Symptomatic lesion category 2 \- 6 on Rutherford scale
- •4\. Thrombosis or stenosis greater than 70% category A, B or C
- •5\. Restenotic or de novo lesion, less than or equal to 20 cm
- •6\. Ipsilateral ankle\-brachial index (ABI) at rest less than or equal to 0\.95
- •7\. Written informed consent
- •Previous inclusion criteria:
- •1\. 45 years and older, either sex
Exclusion Criteria
- •Current exclusion criteria as of 16/07/2008:
- •1\. Contraindication to angiography or angioplasty or to clopidogrel
- •2\. Recurrent lesion already treated by stenting
- •3\. Prior irradiation or infection to the expected radiation site
- •4\. Prior use of doxorubicine or other radiosensibilising agent
- •5\. Patient susceptible to be pregnant
- •6\. Hemodynamically significant lesion above the femoropopliteal lesion
- •7\. Inhability to give informed consent or to complete the follow\-up
- •8\. Life expectancy of less than 2 years
- •9\. Superficial femoral lesion treated with a view to a lower limb bypass initiated below site of femoro\-popliteal endovascular revascularisation
Outcomes
Primary Outcomes
Not specified
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