Evaluation of external beam radiation to prevent restenosis after femoropopliteal stenting

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 214

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
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 15 cm
6. Ipsilateral ankle-brachial index (ABI) at rest less than or equal to 0.85
7. Written informed consent

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
10. Femoro-popliteal lesion located at least 2 cm below the groin (4 cm in the case of obese patients). For purposes of radiography the lesion should be located at 2 cm (4 cm in the case of obese patients) below the lower edge of the femoral head.

Previous exclusion criteria:
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A lower restenosis rate (greater than or equal to 50%) in the radiation group than in the control group, as measured by angiography 24 months after stenting

Secondary Outcome Measures

Name	Time	Method
A higher ankle-brachial index, a lower reintervention rate, and a lower amputation rate in the radiation group, with similar side-effects and complications in both groups