Atherosclerosis Arterial plaque
Conditions
Interventions
The Kaminari Medical intravascular ultrasound and photo acoustic (IVPA) system is a dual modality intracoronary imaging device. IVUS and photoacoustic (PA) modalities are combined in one device for si
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Age >18years?Symptoms of stable angina?Evidence of intermediate coronary artery disease (30-70% DS) on either angiography or CTA in at least one major coronary artery within 3 months prior to consent?Indication for coronary angiography with the option for revascularization.
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Subject unwilling or unable to provide written informed consent.?Subject unwilling to comply with study protocol?Severe coronary calcification or tortuosity precluding intracoronary imaging evaluation ?Previous bypass surgery or stenting of target vessel?Previous heart transplantation?Renal failure (eGFR<40ml/min) ?TIMI flow <3 in target vessel?Active infection, bacteremia or sepsis ?Patients with major coagulation system abnormalities ?Patients with severe hemodynamic instability or shock ?Patients diagnosed with coronary artery spasm ?Aorto-ostial disease (angiographic DS >50%) ?Patients treated on systemic steroids ?PregnancyKnown allergy to contrast medium, heparin or aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints:Successful acquisition rate: Percentage (%) of pullbacks where both IVUS and PA data were successfully acquired in vivo from the same pullback.Safety: Number of device-related adverse events (e.g. spasm (>30% decrease in reference vessel diameter (RVD) on angiography), thrombus (OCT defined), dissection or perforation as identified by OCT or angiography?).Pre and post IVPA lab tests: (fragmented erythrocytes/schistocytes, hemoglobin (Hb), lactate dehydrogenase (LDH), unconjugated bilirubin, Haptoglobin (Hp), plasma free hemoglobin (PFH). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints Visibility of vascular features: Proportion of frames in which lumen and EEM border can be identified??, excluding areas with calcifications or side branchesLipid visualization: Proportion of frames with OCT detected lipid (angle >60 degrees) co-located with IVPA Usability/integration: ?Proportion of cases where the catheter is successfully advanced across the target segment and retrieved from the guiding catheter without complications and not showing signs of thrombus or visible signs of damage to the catheter. ?Procedure time: preparation time, operational time (total time from device insertion to removal) for both IVPA and OCT | — |
Countries
Netherlands
Contacts
Public ContactJ. Daemen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed