Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
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

Mr RB Galland

ORCID ID

Contact details

Department of Surgery
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
+44 (0)118 987 7419
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0199119925

Study information

Scientific title

Prospective randomised controlled trial of femoropopliteal stenting in patients with critical ischaemia

Acronym

Study hypothesis

In patients with critical ischaemia, does femoropoliteal stenting improve patient outcome over angioplasty?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Critical ischaemia

Intervention

Femoropoliteal stenting vs angioplasty

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patency of superficial femoral and popliteal artery at 6 and 12 months
2. Wound healing. Need for further revascularisation
3. Amputation (level)
4. Morbidity and mortality

Secondary outcome measures

Not provided at time of registration

Overall trial start date

09/10/2002

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

110 adults - 55 in each arm - if angiogram shows stenosis or occlusion in femoral or popliteal arteries, lesion is amenable to angioplasty and therefore IIS, angioplasty is first line treatment.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

09/10/2002

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Berkshire Hospital
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Berkshire and Battle Hospitals NHS Trust (UK)

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