Ischaemic heart disease, specifically complex coronary calcification Circulatory System
Conditions
Interventions
This is an observational study of patients treated with orbital atherectomy with optical coherence tomography for complex coronary calcification. The use of orbital atherectomy is routine practice and
Sponsors
University Hospitals Dorset NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or over 2. Orbital atherectomy usage, or attempted orbital atherectomy for coronary calcification felt to be significant (whether that be based on a fluoroscopic or optical coherence tomography assessment) by the supervising interventional cardiologist and meeting one of the following entry criteria: non-crossable calcification; Fujino optical coherence tomography calcification score of 4; balloon undilatable lesion. 3. Patient willing to be included in the registry 4. Intended optical coherence tomography-guided percutaneous coronary intervention (minimum of two attempted runs: postorbital atherectomy and final run post stent optimization). 5. In addition, where optical coherence tomography will cross the lesion, a run will be performed pre-orbital atherectomy (to characterise the calcium morphology and volume) 6. An optical coherence tomography run is mandated following any other calcium modification strategy utilized (to evaluate whether the additional modification demonstrates a significant additional modification of the calcium on optical coherence tomography) 7. Planned use of Xience stents 8. Denovo disease 9. Declared PCI strategy (planned direct viper wire of vessel, need for intravascular lithotripsy/speciality balloons and stent strategy) prior to percutaneous coronary intervention procedure
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. Unable to give informed consent 3. percutaneous coronary intervention performed without optical coherence tomography attempt 4. No orbital atherectomy use 5. Planned treatment of a lesion that includes an area previously treated with a stent 6. Treatment of a bypass graft 7. PCI within the preceding 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target vessel failure (TVF) at one year, a composite of cardiac death, target vessel revascularization (TVR), and target vessel myocardial infarction (TVMI), measured using data collected in patient medical records at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed using data collected in patient medical records at one timepoint: 1. Cardiac death, TVMI, TVR at one year 2. Presence of procedural complications 3. Residual angiographic stenosis <50% 4. Optical coherence tomography expansion index, minimal stent area, presence of edge dissections, eccentricity index, presence of malposition 5. Impact of orbital atherectomy and any other calcium modification device utilised on calcium (volume reduction, presence of fractures) 6. Procedural duration, change in management strategy with orbital atherectomy/optical coherence tomography | — |
Countries
England, United Kingdom
Contacts
Public ContactSarah Savage
Outcome results
None listed