Myoccardial infarction
Conditions
Interventions
OFDI Cathlab procedure
After stenting, patients will undergo the Optical Frequency Domain imaging.
The imaging region will be defined based on angiographic landmarks, such as
side branch take-offs,
Sponsors
Terumo
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is at least 18 years of age 2. Patients with ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with >=2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab =20 min and having an angiographically visible stenosis (>30%) or TIMI2.0 mm by visual assessment)
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9, contrast 3. Diameter Stenosis 50%) 5. Unprotected left main coronary artery stenosis >30% by visual assessment 6. Distal vessel occlusion 7. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication from placement of an OFDI catheter 8. Fibrinolysis prior to PCI 9. Known thrombocytopaenia (PLT30%) if the infarct-related artery is mid or distal-RCA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Flow Area post-stenting assessed by OFDI | — |
Secondary
| Measure | Time frame |
|---|---|
| OFDI endpoint post procedure: 1. Minimal Flow Area post-stenting assessed by OFDI normalized for observed/predicted stent area OFDI endpoints post procedure and at 6-month: 2. Mean Flow area/volume 3. Intraluminal defect area/ volume 4. Mean Stent area/volume 5. Percent of malapposed struts 6. Incomplete Stent Apposition (ISA)area/volume At 6 months, the following variables will be additionally assessed: 7. Percent of struts with coverage 8. Healing Index 9. Tissues prolapse area/volume 10. Procedure success (attainment of | — |
Countries
Netherlands
Outcome results
None listed