I25
Conditions
Interventions
Group 1: CT guided percutaneous coronary intervention arm
Group 2: Standard angiography based percutaneous coronary intervention arm
Sponsors
Universitätsklinikum Erlangen Medizinische Klinik 2
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years of age. 2. Available coronary CT angiography data set 3. Obstructive coronary artery disease with at least one lesion causing > 50% stenosis in a coronary segment planned for percutaneous revascularisation according to clinical decision making. 4. Evidence of myocardial ischemia e.g. stable angina, silent ischemia, unstable angina suitable for elective PCI. 5. Good CT image quality with absence of artefacts in the affected coronary segment 6. No more than 2 target lesions requiring PCI are present in any single vessel, and no more than 2 target vessels are allowed. (PCI to non-target vessels are allowed after 48 hours of index PCI). 7. The patient signing a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Age >85 years 2. Target lesion location in a previously revascularized segment (stents or coronary artery bypass grafting) 3. Left main coronary artery stenosis 4. Patients with status post complicated PCI 5. Cardiogenic shock or hemodynamic instability 6. Creatinine clearance < 30 ml/l/min/1.73 m² as calculated by MDRD formula and not on dialysis. 7. Left ventricular ejection fraction < 30% 8. Planned cardiac or non-cardiac surgery within 24 months after index procedure 9. Prior PCI within the target vessel(s) within 12 months. 10. Any prior PCI in a non-target vessel within 24 hours before study or within 30 days if unsuccessful or complicated. 11. Planned use of a stent < 2.5 mm in diameter 12. Ostial left main stenosis or ostial RCA stenosis 13. Patients with chronic renal insufficiency with GFR < 30 ml/min/1.73 m² 14. Patients actively participating in another study without completion of the primary endpoint or follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is ‘optimal stent deployment’ which is a composite technical endpoint defined as: a) absence of malapposition, b) stent expansion = 80% and c) absence of edge dissections. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical end-point: Target vessel failure (TVF) defined as composite time-to-first event rate of cardiac death, target vessel myocardial infarction or ischemia-driven target vessel revascularisation assessed at a minimum of 1 year and up to 2 years. 2) Imaging Endpoints: a) Stent expansion: Stent expansion is defined by the MSA achieved in the proximal and distal stented segment relative to their respective reference lumen area measured in final post-PCI OCT. The stent length is divided into 2 equal segments (proximal and distal) except for lesions containing a bifurcation (visually estimated side branch = 2.5 mm). In the presence of a bifurcation, the division of the stented segment is based upon the mid-point of the side-branch. i. Acceptable stent expansion (categorical variable): the MSA of the proximal segment is = 80% of the proximal reference lumen area and the MSA of the distal segment is = 80% of the distal reference lumen area. ii. Unacceptable stent expansion (categorical variable): the MSA of the proximal segment is < 80% of the proximal reference lumen area and/or the MSA of the distal segment is <80% of the distal reference lumen area. b) Stent malapposition: defined as frequency (%) of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of = 0.2 mm and not associated with any side-branch. Malapposition will be further classified as major if associated with unacceptable stent expansion as defined above and minor if associated with acceptable stent expansion as defined above. | — |
Countries
Germany
Contacts
Public ContactMohamed Marwan
Universitätsklinikum ErlangenMedizinische Klinik 2
Outcome results
None listed