The Hull and East Yorkshire Angioplasty (HEYA): 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 arteries

Hull and East Yorkshire Angioplasty (HEYA) pilot study and randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31383218

Enrollment

Registered

2014-03-10

Start date

2014-04-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claudication Circulatory System Peripheral vascular disease, unspecified

Interventions

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 block

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Any patient (Male and Female over age 18, no age limit) with symptomatic arteriosclerotic disease of the Superficial Femoral and Popliteal Artery

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026