I20 I21 I22 I23 I24 I25
Conditions
Interventions
Group 1: a total of 100 people
- Data collected during treatment are systematically recorded and subsequently analyzed.
The study project runs as follows:
1. Review of inclusion and exclusion crite
Group A and B.
Group A includes patients with an FFR value <0.9. In these patients the OCT images are used by the operators in order to decide whether and how to optimise the result of stenting (see
Sponsors
Universitätsklinik für Kardiologie und Angiologie
Eligibility
Sex/Gender
All
Age
30 Years to 90 Years
Inclusion criteria
Inclusion criteria: - Participant is willing and able to give informed consent for participation in the study - Angiogram shows haemodynamically relevant complex lesion (ACC–AHA class B2/C) suitable for PCI and suitable for the use of intravascular imaging (OCT)
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following are known to apply: - Patients in whom safety or clinical concerns preclude participation. - ST elevation myocardial infarction - Anaemia (Hb < 7 mmol/l) - Pregnancy, trying for a baby or breast feeding - Revascularization by mean of balloon angioplasty without stenting - Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant - Presentation with cardiogenic shock - Unconscious on presentation - Contraindications to adenosine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of a study specific treatment algorithm on final FFR after PCI measured in the target vessel: - baseline versus proportion of patient with FFR measured at the end of optimisation procedure (final FFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| The MD-OPCI study aims to assess the frequency of intracoronary pathologies after PCI that potentially lead to an impaired FFR using OCT according to CLI-OPCI II study criteria: 1. Frequency of: - Stent-edge dissection - Geographical miss/Reference lumen narrowing - Stent-malapposition - In-stent minimum lumen area (MLA) < 4.5 mm2 - In-stent MLA <70% of the average reference lumen area - Intrastent plaque/thrombus protrusion 2. Frequency of a significant pressure step up during pressure wire pullback during maximal hyperaemia. | — |
Countries
Germany
Contacts
Public ContactMathias Wolfrum
Universitätsklinik für Kardiologie und Angiologie
Outcome results
None listed