Condition category
Circulatory System
Date applied
24/02/2006
Date assigned
24/02/2006
Last edited
04/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eric Therasse

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-78566

Study information

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

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Overall trial start date

01/10/2005

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

214

Participant 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

Recruitment start date

01/10/2005

Recruitment end date

30/09/2010

Locations

Countries of recruitment

Canada

Trial participating centre

Hôtel-Dieu du CHUM
Montreal
H2W 1T8
Canada

Sponsor information

Organisation

Hôtel-Dieu de Montréal (Canada)

Sponsor details

3840 rue St-Urbain
Montréal
H2W 1T8
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes