Plain English Summary
Background and study aims
Peripheral Arterial Disease (PAD) is a disease that is caused by accumulation of fatty deposits in the blood vessels that supply the leg muscles. In the western world, it affects 20% of adults older than 55 years. This is about 27 million people in Europe and the United States. This disease can be silent in nature with patients presenting to their doctor with intermittent pain associated with exercise and relieved by rest. The treatment, called Peripheral Transluminal Angioplasty (PTA), involves puncturing an artery in the leg and inserting a balloon that will be inflated at the point of blockage to increase the blood supply to the leg. At present, there is very little evidence regarding the most effective length of time for balloon inflation, and the long term effect depends on the operator and the centre. With this study we aim to find out if using a specific balloon inflation time can improve the treatment outcomes and the patient's quality of life.
Who can participate?
This study aims to recruit 50 patients suffering from symptomatic arteriosclerotic disease and who have been selected to undergo Peripheral Transluminal Angioplasty (PTA).
What does the study involve?
PTA will involve puncture of an artery in the leg and insertion of a balloon that will be inflated at the point of blockage to increase the blood supply to your leg. Patients will be allocated randomly into one of two groups: a 60 second group or a 180 second group. If you are in the 60 second group and the initial inflation fails, then a further 180 second inflation will be performed. If further treatment is required after the balloon inflation has occurred then this will be performed. This will lead to four groups of patients:
1. Successful angioplasty with 60 seconds
2. Successful angioplasty with 180 seconds
3. Successful angioplasty with 60 + 180 seconds
4. Unsuccessful angioplasty requiring further immediate treatment
Patients will then take part in a questionnaire that will ask about exercise tolerance and general well-being. Follow up will be at 8 weeks, where the patient will be checked after post procedure and their blood pressure readings are taken. The 1-year follow-up is an appointment specifically for those patients in the study and will involve repeat questionnaires to see the effect on quality of life and exercise capacity.
What are the possible benefits and risks of participating?
There is no clinical benefit to participating in the study. However, taking part in a clinical study is a rewarding process. There are no additional risks from undertaking this study. The general risks of the procedure are bleeding and infection
Where is the study run?
The study will be run at the Hull Royal Infirmary, UK.
When is the study starting and how long is it expected to run for?
The trial is expected to start recruitment from late March to early April 2014 and will aim to finish mid-2015, with full follow-up of patients performed by mid-2016.
Who is funding the study?
The British Society of Interventional Radiology (BSIR), UK.
Who is the main contact?
Dr Aubrey Smith
aubrey.smith@hey.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13/YH/0407
Study information
Scientific title
Hull and East Yorkshire Angioplasty (HEYA) pilot study and randomised controlled trial
Acronym
HEYA
Study hypothesis
Null hypothesis: Balloon angioplasty inflation time does not affect quality of life outcomes and long-term arterial patency in the peripheral arterial tree.
Ethics approval
NRES Committee Yorkshire & The Humber - Humber Bridge, 15/01/2014, ref.:13/YH/0407
Study design
Three-year pilot study designed as an randomised controlled trial (RCT)
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
Claudication
Intervention
Peripheral Transluminal Angioplasty of the superficial femoral and popliteal artery will involve puncture of an artery in the leg and insertion of a balloon that will be inflated at the point of blockage to increase the blood supply to your leg. Patients will be randomly allocated to one of two groups:
Group 1: a 60 second balloon angioplasty inflation time
Group 2: a 180 second balloon angioplasty inflation time
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Balloon angioplasty time effect on patient's quality of life
1. Subjective: Walking Impairment Questionnaire.
2. Objective: Short Form 36 (SF-36)
3. Cost-effectiveness analysis: SF-6D
Secondary outcome measures
Assessment of post angiographic outcome:
1. Pre-procedure assessment of vasculature
1.1. USS Duplex or
1.2. MRA
2. Immediate Post Procedure Angiographic assessment. Images scored by two independent observers using the Hull 'Pre and post angioplasty scoring' and peripheral run off weighting score.
3. Post Angiographic outcome
3.1. ABPI post procedure (at 8 weeks and 1 year).
3.2. USS Duplex 1 year. Measurement of waveform and peak velocities to assess stenosis post angioplasty
4. Re-intervention rate
Re-intervention will be recorded at follow up and interpreted as 'immediate': If the initial angioplasty at time of procedure has failed to prevent the stenosis and further treatment is required then this would constitute 'Immediate re-intervention'. Post angioplasty intervention is any other intervention, radiological or surgical, that is required in the time period of the study after the procedure has been performed.
Overall trial start date
01/04/2014
Overall trial end date
31/08/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Any patient (Male and Female over age 18, no age limit) with symptomatic arteriosclerotic disease of the Superficial Femoral and Popliteal Artery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Preprocedure
1. Patient presenting with critical limb ischaemia
2. If no peripheral run off present (TASC D lesions greater than 4 cm)
3. Patient lacks capacity i.e requires Consent Form 4
4. Patient identified as being on any other trial
5. Calcium channel blocker
6. Concurrent Iliac disease.
7. Total lesion size greater than 10 cm
8. <18 years of age
9. Pregnant
Procedure
1. Patient is deemed unfit for procedure
2. Patient unable to tolerate allotted balloon inflation time
3. Severe unforeseen complication e.g. anaphylaxis
Recruitment start date
01/04/2014
Recruitment end date
01/06/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
c/o Mr James Illingworth
Office 12
Daisy Building
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Society of Interventional Radiology (BSIR) (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