Topic: Cardiovascular disease
Conditions
Interventions
Following the consenting process the intervention begins in the Catheter laboratory:
1. Angiographically guided stent placement: This is the standard care pathway, the patient has the
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A participant may enter study if ALL of the following apply: 1. Adults of either sex aged 30 to 90 years who are undergoing EITHER, 1.1. Elective PCI for the treatment of CAD OR 1.2. Urgent PCI for the treatment of ACS 2. Patients who are willing and able to give written informed consent for participation in the study 3. Patients who are anticipated to have at least a 20 mm stent length in at least one lesion
Exclusion criteria
Exclusion criteria: A participant may not enter study if ANY of the following apply: 1. Patients unable to provide written informed consent. 2. Patient undergoing emergency PCI 3. Patients that have had previous PCI within the target vessel. 4. Women who are pregnant or breast feeding 5. Haemodynamic instability 6. Renal impairment (eGFR =50 ml/min) 7. Multivessel PCI (>2 vessels) during a single procedure 8. Left main stem disease 9. Estimated angiographic vessel calibre 4.5mm 10. Additional significant disease (>50% stenosis) in same vessel proximal or distal to culprit lesion 11. Target vessels / lesions of excessive tortuosity 12. Patients participating in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the difference in minimal luminal area (MLA) immediately after the completion of PCI between the OCT-guided and the angiographically guided PCI groups. This outcome will be assessed by processing the digitally stored OCT images. | — |
Secondary
| Measure | Time frame |
|---|---|
| In the OCT-guided and angiographically guided groups: 1. To quantify and compare the prevalence of strut apposition, edge dissection and plaque prolapse. This will be determined from the images taken to assess the primary endpoint 2. To compare the nature and extent of additional interventions indicated from OCT images of the deployed stent, such as additional balloon dilations or further stenting 3. To quantify and compare the PCI procedure duration, the volume of contrast used and the X-ray dosage 4. To quantify and compare the number of major clinical events at 12 months follow-up In OCT-guided group only: Information about how the pre-deployment OCT images informed the choice of treatment strategy and stent | — |
Countries
United Kingdom
Outcome results
None listed