Comparing two methods of estimating the severity of individual narrowings in heart arteries, when there is more than one narrowing
| ISRCTN | ISRCTN18106869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18106869 |
| IRAS number | 293563 |
| Secondary identifying numbers | IRAS 293563 |
- Submission date
- 06/05/2021
- Registration date
- 14/05/2021
- Last edited
- 17/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Angina and heart attacks are caused by narrowings within blood vessels supplying the heart. Individual narrowings that need treatment are usually identified by making an educated guess of the effect that each will have on blood flow, based on the appearance of the artery on an angiogram (an invasive x-ray procedure that involves injecting dye into each heart artery). However, doctors can now accurately determine the effect of a narrowing on blood flow using a pressure wire to measure fractional flow reserve (FFR) or instantaneous flow reserve (iFR) during the angiogram.
People who have blockages in the blood vessels in their heart are often offered a stent procedure. Research has shown that stent procedures are generally safe, prevent future heart problems and can improve people’s symptoms. In a significant number of patients, the blood vessel supplying the heart (also known as coronary arteries) has more than one narrowing. In this situation it can be difficult to know which of the two or more narrowings require stenting. This study will investigate how accurate pressure wire measurement guided predictions are at determining the severity of each narrowing in a coronary artery.
Who can participate?
Patients are invited to join the trial if they are either scheduled to have a coronary angiogram which may show narrowings that require stenting, or have had an angiogram that demonstrated they have narrowings of the blood vessels in their heart and they need a stent procedure.
What does the study involve?
This study will involve 130 people having stent procedures. In order to make a fair comparison between the two commonly used pressure wire measurement methods (FFR and iFR), the researchers will perform both measurements in all patients. Patient management will be guided by one of these pressure wire methods, either FFR or iFR, this will be decided at random (like tossing a coin). The decision will not be made by the doctor.
What are the possible benefits and risks of participating?
There are no direct benefits from taking part in this study over the usual standard clinical care of the patient's condition. The researchers will obtain very useful information from taking the extra measurements in the catheter laboratory using the pressure wires. The information from this study might help improve the treatment of patients with coronary artery disease in the future. Patients will not be paid for participating in the study.
As part of this study, the researchers will use an additional pressure wire (already used in clinical practice) to make additional recordings to normal care during which they will also be using a drug called adenosine. Therefore, if patients take part in this study, these additional recordings for research will result in their catheter laboratory procedure being lengthened by about 5 to 10 minutes with a small increase in time (no more than 1-2 minutes) exposed to the adenosine infusion but with no significant increase in the risk of the procedure. This increased procedural time will result in increased ionising radiation (X-ray) dose.
Where is the study run from?
Guy's and St Thomas' NHS Foundation Trust and Kings College London (UK)
When is the study starting and how long is it expected to run for?
September 2020 to August 2025
Who is funding the study?
Abbott Vascular (USA) with an unrestricted research grant to King’s College London (UK)
Who is the main contact?
Dr Matthew Li Kam Wa
SERIAL-Trial@kcl.ac.uk
Contact information
Scientific
The Rayne Institute
St Thomas’ Hospital
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)2071881048 |
|---|---|
| divaka.perera@kcl.ac.uk |
Public
Rayne Institute, 4th Floor Lambeth Wing, St Thomas’ Hospital
London
SE1 7EH
United Kingdom
| mlikamwa@nhs.net |
Study information
| Study design | Prospective multi-centre cluster randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Systematic Evaluation by Randomisation of Intracoronary physiological techniques for Assessing tandem Lesions (SERIAL) |
| Study acronym | SERIAL |
| Study objectives | To compare the accuracy of two different systems (that are routinely used clinically) for estimating the significance of individual lesions in serially diseased coronary arteries. |
| Ethics approval(s) |
Approved 17/08/2021, Wales Research Ethics Committee 1 (Health & Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)1792 606334; Wales.REC1@wales.nhs.uk), ref: 21/WA/0238 |
| Health condition(s) or problem(s) studied | Coronary artery disease (CAD) with serial stenoses |
| Intervention | Randomisation will be stratified block randomisation with varying block sizes via the King's College London Clinical Trials Unit online portal. Blocks will be stratified by age and sex. CAD with serial lesions will be assessed systematically in the same patient by the use of two intracoronary pressure sensing guide wires. In this way, both instantaneous wave free flow reserve (iFR) pullback Scout (Volcano Phillips) and fractional flow reserve (FFR) pullback solution (Abbott/Coroventis) can be compared. The operator will base medical strategy on the randomised modality only and be blinded to results from the non-randomised system. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | iFR Pullback (Volcano Phillips), FFR Pullback (Abbott/Coroventis) |
| Primary outcome measure | The accuracy of iFR Pullback (Volcano Phillips) and FFR Pullback (Abbott/Coroventis) at predicting the final Fractional Flow Reserve (ratio of distal and aortic pressures) after treatment of one lesion in serial coronary artery disease, measured using physiological intracoronary pressure measurements taken during an angioplasty procedure (baseline) |
| Secondary outcome measures | Secondary efficacy outcomes: Change in management strategy following full physiological evaluation of serial coronary artery disease, assessed by operator questionnaire responses during the procedure (baseline) Secondary exploratory outcomes: Major adverse cardiovascular events (target vessel revascularisation, myocardial infarction, stroke, death), obtained through follow-up telephone calls at 30 days and 1 year |
| Overall study start date | 24/09/2020 |
| Completion date | 01/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 87 |
| Key inclusion criteria | Current participant inclusion criteria as of 14/07/2021: 1. A focal lesion on angiography (at least 50% diameter stenosis) in a coronary artery 2. One of the following: 2.1. A second focal lesion (at least 50% diameter stenosis) which the operator would consider treating with separate (non-overlapping) stents 2.2. A segment of diffuse disease 3. Target vessel diameter of at least 2.5 mm, suitable for passing a pressure wire Previous participant inclusion criteria: 1. A focal lesion on angiography (at least 50% diameter stenosis) in a coronary artery and either a second focal lesion (at least 50% diameter stenosis) or a segment of diffuse disease, which the operator would consider treating with separate (non-overlapping) stents 2. A vessel diameter of at least 2.5 mm, suitable for passing a pressure wire |
| Key exclusion criteria | 1. ST-elevation myocardial infarction (STEMI) 2. Target vessel is considered the culprit for an Acute Coronary Syndrome (ACS) <72 hours before consent 3. Vessels protected by a graft with a history of previous coronary artery bypass grafting 4. Age <18 years 5. Unable to provide written informed consent (IC) 6. Known pregnancy or breastfeeding at time of randomisation |
| Date of first enrolment | 23/08/2021 |
| Date of final enrolment | 01/08/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE1 7EH
United Kingdom
London
SW3 6NP
United Kingdom
Leicester
LE3 9QP
United Kingdom
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Sponsor information
Hospital/treatment centre
Westminster Bridge Road
London
SE1 7EH
England
United Kingdom
| Phone | +44 (0)2071887188 |
|---|---|
| pals@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/Home.aspx |
"ROR" |
https://ror.org/00j161312 |
University/education
The Strand
London
WC2R 2LS
England
United Kingdom
| Phone | +44 (0)207 836 5454 |
|---|---|
| kingshealthpartners@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 27/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The researchers plan to publish the results of this study in leading peer-reviewed journals in the field of Cardiology. In addition, it is intended that the findings from this study will be presented as abstracts at key public meetings including the British Cardiovascular Society, European Society of Cardiology, American Heart Association, American College of Cardiology and Transcatheter Cardiovascular Therapeutics. |
| IPD sharing plan | Anonymised intracoronary pressure data and basic demographic data will be stored on secure King's College London servers. Participants will be identified only by a unique study ID number. All patient identifiable data and procedure records will be held by individual recruiting hospitals in line with their own Information Governance policies. No identifiable data will be transferred to the central study team. All patients will have given informed consent on the use of their data, how and where it will be stored and for how long. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | 25/07/2024 | 25/07/2024 | No | No | |
| Results article | 14/07/2025 | 17/07/2025 | Yes | No |
Additional files
Editorial Notes
17/07/2025: Publication reference added.
21/08/2024: Total final enrolment added.
25/07/2024: The statistical analysis plan was uploaded as an additional file.
08/07/2024: The following changes were made:
1. The overall study end date was changed from 01/06/2025 to 01/08/2025.
2. The recruitment end date was changed from 01/06/2024 to 01/08/2024.
3. Study participating centre The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust was added.
4. The intention to publish date was changed from 01/06/2025 to 27/10/2024.
5. The plain English summary study contact name was changed.
6. A study contact was replaced.
01/06/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 01/06/2023 to 01/06/2024.
2. The overall study end date was changed from 01/06/2024 to 01/06/2025.
3. Royal Brompton Hospital and Glenfield Hospital NHS Trust were added to the study participating centres.
19/08/2021: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 31/08/2021 to 23/08/2021.
14/07/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/06/2021 to 31/08/2021.
2. The participant inclusion criteria have been updated.
12/05/2021: Trial's existence confirmed by Abbott Vascular.
