Coronary Bifurcation LesionsNCT06971718
Coronary Bifurcations With Ischaemia and Flow Assessment
An observational study of Coronary Bifurcation Lesions, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. Narrowings are usually treated using metal scaffolds called drug eluting stents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bifurcation Lesions
- What is being tested?
- Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2023to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.
Who may be able to join
- Age 18 or over
- Any bifurcation lesion amenable to a provisional main vessel treatment strategy
- A main vessel diameter of 2.5mm or more and side branch diameter of >2mm
- Any patient with stable angina, silent ischaemia, unstable angina or NSTEMI
- Able to give informed consent
Who cannot join
- Cardiogenic shock
- LVEF <30%
- STEMI (as unable to give informed consent)
- eGFR <30
- Severe asthma contraindicating use of adenosine
- High degree AV block on 12 lead ECG precluding the use of adenosine
Show all 9Show fewer
- Pregnancy
- Inability to consent
- Left main stem coronary bifurcation lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Norwich Medical School, University of East Anglia
Norwich, Norfolk, NR47TJ
Natasha Corballis, 01603286286, natasha.corballis@nnuh.nhs.uk
About this study
Official title: Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation
The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. Narrowings are usually treated using metal scaffolds called drug eluting stents. However, in one in five cases where the narrowing occurs at a branching point, treating it with stents is more challenging and can cause complications. A possible alternative treatment is using a special type of balloon called a drug-coated balloon. This balloon is inflated in the blood vessel and releases medicine to help widen the blood vessel and the procedure is completed without leaving any metallic scaffold behind.
This study aims to compare drug coated balloons with drug eluting stents to see which treatment works better for narrowing that occurs at branching points. We will used advanced imaging techniques to create computer models of blood flow in the vessels, and we will follow up with patients over tie to see how well the treatments work.
- Conditions
- Coronary Bifurcation Lesions
- Being tested
- Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
- Keywords
- Drug coated balloons, Coronary bifurcation lesions, Computational flow dynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatmentDiagnostic test
Also called Optical coherence tomography
OCT and pressure wire of the main vessel and side branch of the bifurcation are undertaken prior to and after treating the lesion and at 3-9 month follow up.
| Study group | Role | What they receive |
|---|---|---|
| Drug eluted stent | Not described Receives: Diagnostic Test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment | |
| Drug coated balloon | Not described Receives: Diagnostic Test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological assessment
Physiological assessment measuring:
- FFR (Main vessel and side branch)
- Wall sheer stress
Measured: 3-9 months
OCT derived anatomical measure
Mean lumen area main vessel and mean lumen area side branch
Measured: 3-9 months
Secondary outcomes (3)
Late lumen loss
Angiographic assessment of late lumen loss in main vessel and side branch
Measured: 3-9 months
Device oriented clinical endpoints
Composite of:
- Cardiovascular death
- Device failure related MI
- Device failure related ischaemia
- Target bifurcation revascularisation
Measured: 3-9 months
Patient focused endpoint: Angina
Seattle angina questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Oct 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionsStudies of the same condition, open and under way.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Vassilios S Vassiliou, Principal investigator, Norwich Medical SchoolSimon C Eccleshall, Principal investigator, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971718
- Sponsor's protocol ID
- 325142
- Status last verified
- Apr 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation
- ClinicalTrials.gov ID
- NCT06971718
- Acronym / sponsor ID
- 325142
- Conditions
- Coronary Bifurcation Lesions
- Keywords
- Drug coated balloons, Coronary bifurcation lesions, Computational flow dynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 May 2025 (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.
The coronary arteries are blood vessels that provide oxygen rich blood to the muscle of the heart. If these vessels become narrowed or blocked, this can lead to chest pain (called angina) or heart attacks. Narrowings are usually treated using metal scaffolds called drug eluting stents. However, in one in five cases where the narrowing occurs at a branching point, treating it with stents is more challenging and can cause complications. A possible alternative treatment is using a special type of balloon called a drug-coated balloon. This balloon is inflated in the blood vessel and releases medicine to help widen the blood vessel and the procedure is completed without leaving any metallic scaffold behind.
This study aims to compare drug coated balloons with drug eluting stents to see which treatment works better for narrowing that occurs at branching points. We will used advanced imaging techniques to create computer models of blood flow in the vessels, and we will follow up with patients over tie to see how well the treatments work.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug eluted stent | – | Diagnostic Test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment |
| Drug coated balloon | – | Diagnostic Test: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.
Key inclusion criteria (5 listed)
- Age 18 or over
- Any bifurcation lesion amenable to a provisional main vessel treatment strategy
- A main vessel diameter of 2.5mm or more and side branch diameter of >2mm
- Any patient with stable angina, silent ischaemia, unstable angina or NSTEMI
- Able to give informed consent
Key exclusion criteria (9 listed)
- Cardiogenic shock
- LVEF <30%
- STEMI (as unable to give informed consent)
- eGFR <30
- Severe asthma contraindicating use of adenosine
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 |
|---|---|---|
| Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatmentAlso: Optical coherence tomographyOCT and pressure wire of the main vessel and side branch of the bifurcation are undertaken prior to and after treating the lesion and at 3-9 month follow up. | Diagnostic test | Drug coated balloon, Drug eluted stent |
Primary outcome
Physiological assessment
Time frame: 3-9 months
Physiological assessment measuring: * FFR (Main vessel and side branch) * Wall sheer stress
OCT derived anatomical measure
Time frame: 3-9 months
Mean lumen area main vessel and mean lumen area side branch
3 secondary outcomes
Late lumen loss
Time frame: 3-9 months
Device oriented clinical endpoints
Time frame: 3-9 months
Patient focused endpoint: Angina
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Related trials for Coronary Bifurcation Lesions
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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.
Vassilios S Vassiliou principal investigator
Norwich Medical School
Simon C Eccleshall principal investigator
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bifurcation Lesions, run by University of East Anglia at 1 site in United Kingdom.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Corballis, MBBS, MRCP (UK), MSc (01603286286, natasha.corballis@nnuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological assessment (time frame: 3-9 months). The study lists 2 primary outcomes in all. 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 14 May 2025.