Clinical trial NCT06971718: Coronary Bifurcations With Ischaemia and Flow Assessment
Official title: Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Bifurcation Lesions
Keywords: Drug coated balloons
Coronary bifurcation lesions
Computational flow dynamics
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Norfolk and Norwich University Hospitals NHS Foundation Trust
First posted: 2025-05-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Pregnancy
* Inability to consent
* Left main stem coronary bifurcation lesions

Primary outcomes:
measure: Physiological assessment
timeFrame: 3-9 months
measure: OCT derived anatomical measure
timeFrame: 3-9 months
Secondary outcomes:
measure: Late lumen loss
timeFrame: 3-9 months
measure: Device oriented clinical endpoints
timeFrame: 3-9 months
measure: Patient focused endpoint: Angina
timeFrame: 12 months
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norwich Medical School, University of East Anglia
state: Norfolk
Study officials:
affiliation: Norwich Medical School
name: Vassilios S Vassiliou
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Simon C Eccleshall
role: PRINCIPAL_INVESTIGATOR
References: