A Study To Evaluate The Safety And Feasibility Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel Interventio

• Conditions: Coronary Artery Disease; Coronary Atherosclerosis; 10011082

• Registration Number: NL-OMON34428
• Lead Sponsor: Miracor medical systems

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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

- 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 <1.8 L/min/m² or assessed by the investigator), pulmonary edema (Killip Class >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 <20%
- History of stroke, any sequelea of a transient ischemic attack (TIA) or reversible ischemic neurological defect (RIND) within 6 months prior to screening
- left bundle branch block
- mitral regurgitation (MR) > 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 <10 g/dl or <6.2 mmol/l)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Duration from successful femoral vein cannulation untill successful<br /><br>placement of PICSO Impulse catheter into the Coronary Sinus.<br /><br>2. Relative increase in collateral flow pressure index (CFpI) during LAD<br /><br>occlusion with and without PICSO.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Number of patients reaching collateral flow pressure index (CFpI) higher<br /><br>than 30% during PICSO.<br /><br>2. Quantitative evaluation of pre-condition effect on relative increase of CFpI.<br /><br>3. The change of ST segment as recorded at Intra coronary ECG measures during<br /><br>balloon inflation</p><br>