I20
Conditions
Interventions
Group 1: Treatment algorithm (1. OCT MLD, 2. R-PCI, 3. OCT MAX)
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. = 18 years 2. Patients undergoing planned stent implantation during a clinically indicated PCI procedure 3. All target lesions must have a visually estimated or quantitatively assessed %DS of either =70%, or =50% plus one or more of the following: an abnormal functional test (e.g. fractional flow reserve, stress test) signifying ischemia in the distribution of the target lesion(s) or biomarker positive ACS with plaque disruption or thrombus. 4. Single or multi-vessel CAD 5. Informed consent
Exclusion criteria
Exclusion criteria: 1. STE-ACS within the last 7 days 2. Unstable NSTE-ACS patients 3. Previous coronary artery bypass graft (CABG) 4. Chronic total occlusion (CTO) 5. Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg) 6. Persistent ventricular arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint 1.Success rate of OCT guided R-PCI (%) 2.Precision of R-PCI as determined by deviation from optimal stent landing zone (distal or proximal) (mm) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Minimal stent area (MSA) 2. Stent expansion o Acceptable stent expansion: MSA of the proximal segment is =90% of the proximal reference lumen area and the MSA of the distal segment is =90% of the distal reference lumen area o Unacceptable stent expansion: MSA of the proximal segment is <90% of the proximal reference lumen area, and/or the MSA of the distal segment is <90% of the distal reference lumen area. o Post-PCI stent expansion (%): MSA divided by the average of proximal and distal reference lumen areas x 100 3. Untreated reference segment disease o Defined as focal disease with untreated Mean Lumen Area (MLA) <4.5 mm2 within 5 mm from the proximal and/or distal stent edges 4. Edge dissections o A) Major (%): =60 degrees of the circumference of the vessel at site of dissection and/or =3 mm in length o B) Minor (%): any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length 5. Stent Malapposition o 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) 6. Safety – MACE (major adverse cardiovascular events) | — |
Countries
Germany
Contacts
Public ContactConstantin von zur Mühlen
Universitätsklinikum Freiburg
Outcome results
None listed