The Pressure-controlled Intermittent Coronary Sinus Occlusion on VentrIcular PERformance Study

Summary

Participation Requirements

Description

In detail, the five stages of the PICSO VIPER study include: Stage 1: Baseline Diagnostic angiography will be performed in the standard manner using appropriate catheters. Pre-stenting coronary physiology parameters, namely fractional flow reserve (FFR), coronary flow reserve (CFR) and index of micr...

In detail, the five stages of the PICSO VIPER study include: Stage 1: Baseline Diagnostic angiography will be performed in the standard manner using appropriate catheters. Pre-stenting coronary physiology parameters, namely fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) will be measured, using a pressure wire, as used for routine clinical measurements in patients undergoing PCI. Via a separate arterial access, a conductance catheter will be inserted retrogradely in the left ventricle for baseline measurements of cardiac pump function . Baseline blood samples will be withdrawn from the CS (via PICSO balloon) and ascending aorta (via coronary guiding catheter used for revascularization) Stage 2: PICSO treatment during pre-dilation The PICSO device will be deployed as already previously described in the literature. Pre-dilation will be performed using an angioplasty balloon at a size determined by the operator, as per standard clinical practice. Balloon will be maintained inflated for a minimum of 1 minute to a maximum of 2 minutes if well tolerated by the patient. Balloon inflation will be performed once with the PICSO device activated and once with PICSO device in standby. The order of this will be determined by randomisation via Sequentially Numbered Opaque Sealed Envelopes. During each balloon inflation measurements of coronary and cardiac function will be performed and blood samples will be collected exactly as in stage 1. Stage 3: Stenting with PICSO support • Stenting is performed as usual clinical practice while the PICSO device is active. The overall duration of PICSO will be no less than 20 minutes, up to a maximum of 45 minutes. Stage 4: Post-stent Physiology Post-stenting coronary and cardiac physiology parameters will be measured using a pressure wire and conductance catheter, respectively. Blood samples will be drawn from the CS and the coronary guide catheter as described in stage 1. Stage 5 Stent post-dilation will be performed using an angioplasty balloon at a size determined by the operator, as per standard clinical practice. Balloon will be maintained inflated for a minimum of 1 minute to a maximum of 2 minutes if well tolerated by the patient. Balloon inflation will be performed in all patients once with the PICSO device activated and once with the PICSO device in standby. The order of this will be the same as in Stage 2 (as determined by Sequentially Numbered Opaque Sealed Envelopes) During each balloon inflation measurements will be made of coronary and cardiac physiology parameters and blood samples will be drawn from the CS and the coronary guide catheter as described in stage 1. Following this, the participant completes and exits the study.

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