Evaluation of external beam radiation to prevent restenosis after femoropopliteal stenting
| ISRCTN | ISRCTN74370657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74370657 |
| Protocol serial number | MCT-78566 |
| Sponsor | Hôtel-Dieu de Montréal (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78566) |
- Submission date
- 24/02/2006
- Registration date
- 24/02/2006
- Last edited
- 04/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eric Therasse
Scientific
Scientific
Hôtel-Dieu du CHUM
Département de Radiologie
3840 St-Urbain
Montreal
H2W 1T8
Canada
| Phone | +1 514 890 8150 |
|---|---|
| eric.therasse.chum@ssss.gouv.qc.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study objectives | The external beam radiation will significantly increase the arterial lumen diameter at the treatment site, two years after stenting and will lead to an improvement of the ankle-brachial index. As of 16/07/2008, this trial record has been updated, and changes to the inclusion and exclusion criteria performed. For more details, please see all changes in these fields under the above update date. |
| Ethics approval(s) | Comités d'evaluation scientifique et d'éthique de la recherche, Équipe Hôpital Notre-Dame du CHUM, Montréal, Québec (Canada) approved on the 9th September 2005. |
| Health condition(s) or problem(s) studied | Peripheral vascular disease/femoropopliteal artery obstruction |
| Intervention | 1. Femoropopliteal stenting: Group A and B 2. External radiation (24 hours post-stenting): Group A 3. Clinical follow-up, evaluation of side effects, ankle-brachial index and Doppler ultrasound (every 6 months): Group A and B 4. Angiography (at 24 months): Group A and B |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 214 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
Hôtel-Dieu du CHUM
Montreal
H2W 1T8
Canada
H2W 1T8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
