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| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug eluted stent |
| ||
| Drug coated balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological assessment | Physiological assessment measuring:
| 3-9 months |
| OCT derived anatomical measure | Mean lumen area main vessel and mean lumen area side branch | 3-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss | Angiographic assessment of late lumen loss in main vessel and side branch | 3-9 months |
| Device oriented clinical endpoints | Composite of:
|
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Inclusion Criteria:
Exclusion Criteria:
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Any patient with coronary bifurcation lesion who fulfills the inclusion criteria and is not precluded by the exclusion criteria is suitable for recruitment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasha Corballis, MBBS, MRCP (UK), MSc | Contact | 01603286286 | natasha.corballis@nnuh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Vassilios S Vassiliou | Norwich Medical School | Principal Investigator |
| Simon C Eccleshall | Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwich Medical School, University of East Anglia | Recruiting | Norwich | Norfolk | NR47TJ | United Kingdom |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| 3-9 months |
| Patient focused endpoint: Angina | Seattle angina questionnaire | 12 months |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |