Coronary Artery Disease Coronary Atherosclerosis
Conditions
Interventions
Patients will be treated with PICSO. This treatment exists of PICSO catheter
placement in the coronary sinus through a femoral vein approach by using a 12F
steerable guiding catheter. During two sho
Sponsors
Miracor medical systems
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subjects at least 18 years of Age - Stable patient - Left Anterior Descending (LAD) Stenosis as assessed by angiography - Able to understand content of and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: - Active and/or treated malignancies within 12 months prior to first Visit - Anatomical Complications (e.g. The system is not able to effectively occlude the coronary sinus) - Presence of significant collateral flow supplying the target vessel (Rentrop 2,3) - Any significant systemic illness or medical condition that could lead to difficulty complying with the protocol; or any concurrent condition(s) which, in the investigator's opinion, would prohibit the subject from completing the study, or in which case the study would not be in the best interest of the subject. - Bleeding or perforation during PCI, pericardial effusion and/or hematoma - Cardiac arrest or arrythmia requiring chest compressions or cardiopulmonary resuscitation - Cardiogenic shock (Cardiac index 2), or hemodynamic instability as assessed by the investigator at the time of cardiac catheterization. - Clinically significant renal disturbance (sMDRD calculated GFR *30mL/min/1,73m²) - Coronary Sinus electrode in place - Acute ST elevation myocardial infarction - Previous Q-wave myocardial infarction within 72 hours prior to screening - Ejection Fraction grade I - mitral stenosis - Patient not currently in sinus rythm - patients on cardiac resynchronization therapy (CRT) or scheduled for CRT implantation - Patients with previous CABG or planned chronic total occlusion revascularization - Pregnancy or active breast-feeding. Urine pregnancy tests will be performed on all women who are not post-menopausal for at least 1 year. - registration in another interventional study - severe anemia at baseline (hemoglobin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Duration from successful femoral vein cannulation untill successful placement of PICSO Impulse catheter into the Coronary Sinus. 2. Relative increase in collateral flow pressure index (CFpI) during LAD occlusion with and without PICSO. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients reaching collateral flow pressure index (CFpI) higher than 30% during PICSO. 2. Quantitative evaluation of pre-condition effect on relative increase of CFpI. 3. The change of ST segment as recorded at Intra coronary ECG measures during balloon inflation | — |
Countries
Netherlands
Outcome results
None listed