Coronary Artery DiseaseBURSTNCT03538067
Balloon Inflation and Plaque Morphology in Revascularisation (BURST)
An observational study of Coronary Artery Disease and Atherosclerosis, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
This study will look at the effects of standardised balloon inflation times, pressure and balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) already referred for coronary intervention will be prospectively enrolled sequentially as they attend the St Thomas' Cardiac Catheterisation Laboratories.
Who may be able to join
- Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) undergoing percutaneous coronary intervention with intracoronary ultrasound (IVUS) guidance
- Patients > 18 years
- De novo coronary stenoses in native coronary arteries
- Written informed consent
Who cannot join
- ST-elevation acute coronary syndrome
- Haemodynamic instability
- Cardiogenic shock
- Severe renal dysfunction (eGFR < 30 ml/min/1.73m2)
- In-stent restenosis
- Chronic total occlusions
- Saphenous vein and arterial bypass grafts
- Patients who are currently enrolled in any other study where involvement in this study would involve significant deviation from either protocol
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Balloon Inflation Techniques and Plaque Characteristics on Stent Under-expansion in Percutaneous RevasculariSaTion (BURST)
This study will look at the effects of standardised balloon inflation times, pressure and balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous coronary intervention (PCI).
Read the detailed description
Patients presenting with symptoms of coronary artery disease (e.g. chest pain - angina) are often treated with stents (referred to as percutaneous coronary intervention, PCI). Stents treat the cause of symptoms by improving blood flow to the heart muscle through expanding a narrowed, or diseased segment within a coronary artery. The procedure involves the inflation of a balloon to expand the stent inside the artery. As part of standard clinical care multiple balloon inflations are required during the procedure. Deficiencies in the expansion of the stent at the time of the procedure are associated serious complications such as stent blockages or re-narrowing of the artery, either of which may not occur until much later.
Improvements to the technique of stent expansion are therefore highly desirable to improve outcomes for patients. A number of factors are thought to influence the success of the procedure, including: the type of balloon used to inflate the stent, the pressure used and the duration of balloon inflation. Another important factor may be the mechanical properties of the narrowed segment of the artery (plaque) and how they interact with the stent. At present however, there is no consensus view and the practise of individual cardiologists consequently remains highly variable.
The aim of this study is better characterise relationship between pressure and duration of balloon inflation, type of balloon used and plaque properties during stent procedures using state-of-the-art imaging. Although assessment of each of these factors by a cardiologist is already included as part of standard care, our research protocol will focus the analysis into a systematic framework to allow conclusions to be drawn. The findings will used better inform cardiologists of the technical modifications that can help improve stenting procedures and translate to better outcomes for patients.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Percutaneous coronary intervention (PCI)
- Keywords
- percutaneous coronary intervention, stent apposition, stent deployment, stent expansion, intravascular ultrasound
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (PCI)Procedure or surgery
Patients will undergo PCI with intravascular ultrasound (IVUS) as part of standard clinical care in accordance with operator discretion. The research protocol will be observational - using IVUS to determine the effects of balloon inflation time, balloon inflation pressure, balloon type, atherosclerotic plaque morphology on stent expansion (minimal luminal area, MLA)
| Study group | Role | What they receive |
|---|---|---|
| Paired sample group | Patients with symptomatic coronary artery disease (stable, NSTEACS) undergoing planned percutaneous coronary intervention with intravascular ultrasound (IVUS) guidance Receives: Procedure: Percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent minimal luminal area (MLA, mm2)
As measured by intravascular ultrasound
Measured: Immediate - peri-procedurally
Secondary outcomes (3)
Plaque characteristics
As determined by virtual histology intravascular ultrasound (VH-IVUS)
Measured: Immediate - peri-procedural
Stent deployment
Determined by intravascular ultrasound (IVUS - MUSIC Criteria)
Measured: Immediate - peri-procedural
Peri-procedural myocardial infarction
In accordance with academic research consortium (ARC) definition
Measured: Immediate - peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Simon Redwood, MD FRCP FACC, Principal investigator, King's College London, Guy's and St Thomas' Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538067
- Sponsor's protocol ID
- 212423
- Acronym
- BURST
- Status last verified
- May 2018
- First submitted
- 31 Jul 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Balloon Inflation Techniques and Plaque Characteristics on Stent Under-expansion in Percutaneous RevasculariSaTion (BURST)
- ClinicalTrials.gov ID
- NCT03538067
- Acronym / sponsor ID
- BURST / 212423
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- percutaneous coronary intervention, stent apposition, stent deployment, stent expansion, intravascular ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the effects of standardised balloon inflation times, pressure and balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous coronary intervention (PCI).
Detailed description
Patients presenting with symptoms of coronary artery disease (e.g. chest pain - angina) are often treated with stents (referred to as percutaneous coronary intervention, PCI). Stents treat the cause of symptoms by improving blood flow to the heart muscle through expanding a narrowed, or diseased segment within a coronary artery. The procedure involves the inflation of a balloon to expand the stent inside the artery. As part of standard clinical care multiple balloon inflations are required during the procedure. Deficiencies in the expansion of the stent at the time of the procedure are associated serious complications such as stent blockages or re-narrowing of the artery, either of which may not occur until much later.
Improvements to the technique of stent expansion are therefore highly desirable to improve outcomes for patients. A number of factors are thought to influence the success of the procedure, including: the type of balloon used to inflate the stent, the pressure used and the duration of balloon inflation. Another important factor may be the mechanical properties of the narrowed segment of the artery (plaque) and how they interact with the stent. At present however, there is no consensus view and the practise of individual cardiologists consequently remains highly variable.
The aim of this study is better characterise relationship between pressure and duration of balloon inflation, type of balloon used and plaque properties during stent procedures using state-of-the-art imaging. Although assessment of each of these factors by a cardiologist is already included as part of standard care, our research protocol will focus the analysis into a systematic framework to allow conclusions to be drawn. The findings will used better inform cardiologists of the technical modifications that can help improve stenting procedures and translate to better outcomes for patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paired sample group | – | Procedure: Percutaneous coronary intervention (PCI)Patients with symptomatic coronary artery disease (stable, NSTEACS) undergoing planned percutaneous coronary intervention with intravascular ultrasound (IVUS) guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) already referred for coronary intervention will be prospectively enrolled sequentially as they attend the St Thomas' Cardiac Catheterisation Laboratories.
Key inclusion criteria (4 listed)
- Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) undergoing percutaneous coronary intervention with intracoronary ultrasound (IVUS) guidance
- Patients > 18 years
- De novo coronary stenoses in native coronary arteries
- Written informed consent
Key exclusion criteria (8 listed)
- ST-elevation acute coronary syndrome
- Haemodynamic instability
- Cardiogenic shock
- Severe renal dysfunction (eGFR < 30 ml/min/1.73m2)
- In-stent restenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (PCI)Patients will undergo PCI with intravascular ultrasound (IVUS) as part of standard clinical care in accordance with operator discretion. The research protocol will be observational - using IVUS to determine the effects of balloon inflation time, balloon inflation pressure, balloon type, atherosclerotic plaque morphology on stent expansion (minimal luminal area, MLA) | Procedure or surgery | Paired sample group |
Primary outcome
In-stent minimal luminal area (MLA, mm2)
Time frame: Immediate - peri-procedurally
As measured by intravascular ultrasound
3 secondary outcomes
Plaque characteristics
Time frame: Immediate - peri-procedural
Stent deployment
Time frame: Immediate - peri-procedural
Peri-procedural myocardial infarction
Time frame: Immediate - peri-procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Redwood, MD FRCP FACC principal investigator
King's College London, Guy's and St Thomas' Hospital, London
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher J Allen, MBChB, MRCP (+44 (0)2071887184, christopher.allen@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent minimal luminal area (MLA, mm2) (time frame: Immediate - peri-procedurally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2018.