Hull and East Yorkshire Angioplasty (HEYA) Pilot Study and RCT
Research type
Research Study
Full title
The HEYA Pilot Study and Randomised Controlled Trial: A study investigating the effects of balloon inflation time on patient quality of life outcomes and long term arterial patency in the Superficial Femoral and Popliteal Arterial angioplasty
IRAS ID
119756
Contact name
Aubrey Smith
Contact email
Sponsor organisation
Hull & East Yorkshire Hospitals NHS Trust
Research summary
Research Question: Does balloon angioplasty time does affect patient quality of life and long-term arterial patency in Superficial Femoral and Popliteal Arteries ?
Peripheral Arterial Disease (PAD) is an increasing phenomenon in the western world affecting 20% of adults older than 55 years. This summates to approximately 27million people in Europe and the United States.
This disease can be insidious in nature with patients presenting to their doctor with intermittent claudication. Claudication is defined as reproducible debilitating pain in the lower extremities associated with exercise and relieved by rest. These symptoms are mainly caused by atherosclerotic disease. Atherosclerosis results in localized, diffuse or multifocal arterial disease causing luminal irregularities and occlusion. Symptom onset is usually at 50% stenosis of the artery.
At present, there is very little science behind the time of balloon angioplasty inflation and the long-term effect on arterial patency and practice tends to be operator and centre dependent. With this project we aim to evaluate if using a specific balloon inflation time can improve the Peripheral Transluminal Angioplasty (PTA) outcomes in the Popliteal and Superficial Femoral Arteries and affect patient quality of life.
As a profession we are aware that occlusion, multi-level disease, diabetes, smoking and length of occlusion are all patient dependent factors that affect arterial patency. This study targets balloon angioplasty inflation time as an operator dependent factor to improve arterial patency post-angioplasty in superficial femoral and popliteal arterial stenosis and occlusion, thus improving symptomatic outcome and treatment in the NHS
A pilot study will be performed to assess the affect of 60 seconds balloon angioplasty vs 180 seconds in 50 patients. If successful, a full randomised control will be performed on the power of this study.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0407
Date of REC Opinion
15 Jan 2014
REC opinion
Further Information Favourable Opinion