Coronary Bifurcations With Ischaemia and Flow Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment.
- Who it may be relevant to
- Registry conditions: Coronary Bifurcation Lesions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug Coated Balloons in Coronary Bifurcation Lesions. A Feasibility Study Looking at Computational Flow Dynamics, Ischaemic and Anatomical Changes to the Bifurcation
Overview
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.
Interventions
- Diagnostic test Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment
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.
Primary outcome measures
- Physiological assessment [Time frame: 3-9 months]
- OCT derived anatomical measure [Time frame: 3-9 months]
Secondary outcome measures (3)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Norwich Medical School, University of East Anglia — Norwich
Identifiers
NCT: NCT06971718 · 325142