Coronary artery disease (CAD) with serial stenoses Circulatory System Atherosclerotic heart disease
Conditions
Interventions
Randomisation will be stratified block randomisation with varying block sizes via the King's College London Clinical Trials Unit online portal. Blocks will be stratified by age and sex.
CAD with ser
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 14/07/2021: 1. A focal lesion on angiography (at least 50% diameter stenosis) in a coronary artery 2. One of the following: 2.1. A second focal lesion (at least 50% diameter stenosis) which the operator would consider treating with separate (non-overlapping) stents 2.2. A segment of diffuse disease 3. Target vessel diameter of at least 2.5 mm, suitable for passing a pressure wire Previous participant inclusion criteria: 1. A focal lesion on angiography (at least 50% diameter stenosis) in a coronary artery and either a second focal lesion (at least 50% diameter stenosis) or a segment of diffuse disease, which the operator would consider treating with separate (non-overlapping) stents 2. A vessel diameter of at least 2.5 mm, suitable for passing a pressure wire
Exclusion criteria
Exclusion criteria: 1. ST-elevation myocardial infarction (STEMI) 2. Target vessel is considered the culprit for an Acute Coronary Syndrome (ACS) <72 hours before consent 3. Vessels protected by a graft with a history of previous coronary artery bypass grafting 4. Age <18 years 5. Unable to provide written informed consent (IC) 6. Known pregnancy or breastfeeding at time of randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy of iFR Pullback (Volcano Phillips) and FFR Pullback (Abbott/Coroventis) at predicting the final Fractional Flow Reserve (ratio of distal and aortic pressures) after treatment of one lesion in serial coronary artery disease, measured using physiological intracoronary pressure measurements taken during an angioplasty procedure (baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy outcomes: Change in management strategy following full physiological evaluation of serial coronary artery disease, assessed by operator questionnaire responses during the procedure (baseline) Secondary exploratory outcomes: Major adverse cardiovascular events (target vessel revascularisation, myocardial infarction, stroke, death), obtained through follow-up telephone calls at 30 days and 1 year | — |
Countries
England, United Kingdom
Contacts
Public ContactMatthew Li Kam Wa
Outcome results
None listed