Coronary Bifurcations With Ischaemia and Flow Assessment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of East Anglia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Cardiogenic shock

LVEF <30%

STEMI (as unable to give informed consent)

eGFR <30

Trial population

Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Optical coherence tomography and pressure wire assessment of the vessel treated before and after treatment

    Diagnostic test

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Drug eluted stent1 intervention
Group B: Drug coated balloon1 intervention

Trial outcomes

Primary outcomes

1

Physiological assessment

Physiological assessment measuring: * FFR (Main vessel and side branch) * Wall sheer stress

Time frame
3-9 months
2

OCT derived anatomical measure

Mean lumen area main vessel and mean lumen area side branch

Time frame
3-9 months

Secondary outcomes

1

Late lumen loss

Angiographic assessment of late lumen loss in main vessel and side branch

Time frame
3-9 months
2

Device oriented clinical endpoints

Composite of: * Cardiovascular death * Device failure related MI * Device failure related ischaemia * Target bifurcation revascularisation

Time frame
3-9 months
3

Patient focused endpoint: Angina

Seattle angina questionnaire

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of East Anglia

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborator