Optical coherence tomography to guide stent placement during percutaneous coronary intervention
| ISRCTN | ISRCTN22628285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22628285 |
| Secondary identifying numbers | 18505 |
- Submission date
- 11/03/2015
- Registration date
- 11/03/2015
- Last edited
- 04/06/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Coronary artery disease (CAD) and its consequences are the leading cause of death and disease in the Western world, leading to major healthcare and economic burdens. CAD is the thickening of the walls of the coronary arteries that supply blood to the heart, caused by the build-up of fatty deposits in these blood vessels. Percutaneous coronary intervention (PCI) is a routine and widely used treatment to reopen narrowed or blocked coronary arteries. PCI is usually performed by feeding a hollow wire (catheter) through the blood vessels to the site of the blockage, inflating a balloon at the tip of the catheter to stretch the artery wall vessel and then placing an expandable metal tube (stent) at the site of the blockage. The stent stays in the wall of the artery in order to keep the artery wall stretched and allow blood to flow freely through the artery. Tools that can take pictures of the inside of the coronary arteries, have contributed substantially to our understanding of the how best to place a stent. Optical coherence technology (OCT) is a method for taking pictures of the inside of the coronary arteries, which provides an image with much greater resolution than current alternatives (e.g. intravascular ultrasound). The definition of the OCT images is at least ten times greater than with ultrasound, which enables very detailed imaging of the artery wall, the fatty deposits and, once placed, the stent. To date, there have been no studies of the usefulness of OCT for improving stent placement and the effectiveness of PCI. In this study we wish to assess whether routine use of OCT to guide stent placement will lead to improved stent placement.
Who can participate?
Patients aged 30 to 90 who are undergoing PCI for the treatment of CAD or acute coronary syndrome
What does the study involve?
Participants are randomly allocated to undergo either angiographically guided or OCT-guided stent placement. Angiographically guided stent placement is the standard care pathway, where a type of X-ray is used to examine the blood vessels. OCT-guided stent placement involves taking pictures of the inside of the coronary arteries to guide decisions about the size and type of stent to use. All patients receive standard hospital follow up. 12 months after their procedure all patients complete a questionnaire.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
March 2014 to May 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Lucy Culliford
lucy.culliford@bristol.ac.uk
Contact information
Scientific
CTEU Bristol, BTC
Level 7 Zone A Queens Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 342 2526 |
|---|---|
| Lucy.Culliford@bristol.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Optical Coherence Tomography to guIde stent placeMent durIng percutaneouS coronary intErvention: a randomised controlled trial |
| Study acronym | OCTIMISE |
| Study hypothesis | The aim of this study is to assess whether routine use of optical coherence technology (OCT) to guide stent placement will lead to improved stent placement and improved clinical outcomes at one year for people with coronary heart disease (CHD). |
| Ethics approval(s) | West Midlands -Coventry and Warwick NRES committee, 25/02/2015, ref: 15/WM/0075E |
| Condition | Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | Following the consenting process the intervention begins in the Catheter laboratory: 1. Angiographically guided stent placement: This is the standard care pathway, the patient has their stent placed using standard treatment plan, once the clinician has stated that they have completed deployment the OCT catheter is taken past the stent(s,) this is known as a 'pullback', to visually record the inside of the lumen. The procedure ends. The patient has standard care and is discharged. Duration is approximately 5 minutes longer than standard care. 2. OCT guided stent placement: After the standard angiogram and review of the lesions, the OCT catheter is used to visualise the inside of the lumen, the clinician uses the images to guide their decisions about size and type of stent used. The catheter is used again to check stent placement, the clinician makes any adjustments or corrections to the stent placement and if necessary another pullback is made to check the stent. Once the clinician is content, that the deployment is complete, a reference pullback occurs. The procedure ends. The patient has standard care and is discharged. Duration is approximately 10 minutes longer than standard care. All patients receive standard hospital follow up. 12 months after their procedure all patients will receive a trial questionnaire. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | To estimate the difference in minimal luminal area (MLA) immediately after the completion of PCI between the OCT-guided and the angiographically guided PCI groups. This outcome will be assessed by processing the digitally stored OCT images. |
| Secondary outcome measures | In the OCT-guided and angiographically guided groups: 1. To quantify and compare the prevalence of strut apposition, edge dissection and plaque prolapse. This will be determined from the images taken to assess the primary endpoint 2. To compare the nature and extent of additional interventions indicated from OCT images of the deployed stent, such as additional balloon dilations or further stenting 3. To quantify and compare the PCI procedure duration, the volume of contrast used and the X-ray dosage 4. To quantify and compare the number of major clinical events at 12 months follow-up In OCT-guided group only: Information about how the pre-deployment OCT images informed the choice of treatment strategy and stent |
| Overall study start date | 04/03/2014 |
| Overall study end date | 01/05/2018 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 128; UK Sample Size: 128 |
| Participant inclusion criteria | A participant may enter study if ALL of the following apply: 1. Adults of either sex aged 30 to 90 years who are undergoing EITHER, 1.1. Elective PCI for the treatment of CAD OR 1.2. Urgent PCI for the treatment of ACS 2. Patients who are willing and able to give written informed consent for participation in the study 3. Patients who are anticipated to have at least a 20 mm stent length in at least one lesion |
| Participant exclusion criteria | A participant may not enter study if ANY of the following apply: 1. Patients unable to provide written informed consent. 2. Patient undergoing emergency PCI 3. Patients that have had previous PCI within the target vessel. 4. Women who are pregnant or breast feeding 5. Haemodynamic instability 6. Renal impairment (eGFR =50 ml/min) 7. Multivessel PCI (>2 vessels) during a single procedure 8. Left main stem disease 9. Estimated angiographic vessel calibre <2.5mm or >4.5mm 10. Additional significant disease (>50% stenosis) in same vessel proximal or distal to culprit lesion 11. Target vessels / lesions of excessive tortuosity 12. Patients participating in another interventional study |
| Recruitment start date | 01/05/2015 |
| Recruitment end date | 01/05/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The findings will be disseminated by usual academic channels, i.e. presentation at international meetings, as well as by peer-reviewed publications and through patient organisations and newsletters to patients, where available. We intend to publish as soon as possible. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/06/2019: This trial formed part of the Bristol NIHR BRU. The proposed trial became redundant before it could be carried out because of software developments and the publication of other trials, primarily the DOCTORS trial. The researchers reviewed options for modifying the trial in November 2015, specifically an amended design based on a software upgrade that provides enhanced measurements. They decided not to pursue this re-designed trial because of the limited time remaining in the BRU award and the cost implications of the revised design. This summary was reported to the NIHR in their 2016 and 2017 reports.
21/05/2019: Internal review.
16/06/2016: Plain English summary added.
