Evaluation of external beam radiation to prevent restenosis after femoropopliteal stenting

ISRCTN ISRCTN74370657
DOI https://doi.org/10.1186/ISRCTN74370657
Secondary identifying numbers 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

Hôtel-Dieu du CHUM
Département de Radiologie
3840 St-Urbain
Montreal
H2W 1T8
Canada

+1 514 890 8150
eric.therasse.chum@ssss.gouv.qc.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProspective, 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 objectivesThe 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) studiedPeripheral vascular disease/femoropopliteal artery obstruction
Intervention1. 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 typeOther
Primary outcome measureA 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 measuresA 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
Overall study start date01/10/2005
Completion date30/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants214
Key inclusion criteriaCurrent 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 criteriaCurrent 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 enrolment01/10/2005
Date of final enrolment30/09/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

Hôtel-Dieu du CHUM
Montreal
H2W 1T8
Canada

Sponsor information

Hôtel-Dieu de Montréal (Canada)
Hospital/treatment centre

3840 rue St-Urbain
Montréal
H2W 1T8
Canada

ROR logo https://ror.org/0468gx405

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-78566)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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