Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study

Launched by INTRATECH MEDICAL LTD. · Sep 22, 2022

Keywords

ClinConnect Summary

The Booster Balloon Catheter, while inflated, causes partial occlusion of CS blood flow and thus increases the coronary sinus venous pressure. It is hypothesized that the utilization of a long pressure plateau, without a complete occlusion of the CS, will enable prolonged and improved redistribution of the venous flow and improve the oxygenation of the border zone (penumbra) of the infarcted myocardium at risk. The improved oxygenation of the ischemic peri-infarcted area is believed to reduce infarct size and may lead to improved short- and long-term outcomes.

This is a First-In-Human stud...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Pre procedural:
• • 1. Age above 18 years of age
• • 2. Clinical presentation of anterior wall STEMI (ST-segment elevation \> 1 mm in two or more contiguous leads between V1 and V4 or new left bundle branch block (LBBB)
• • 3. STEMI culprit lesion in LAD
• • 4. \< 24-hour duration from time of symptom onset until admission to the emergency room
• • 5. Patient providing informed consent compatible with the requirement of the institutional ethical committee.
• • 6. Patient and physician agree to all required follow-up procedures and visits
• Angiographic inclusion criteria:
• • 7. Coronary sinus diameter of 10 mm
• • 8. PCI is indicated for culprit lesion in the LAD with planned use of a stent
• • 9. Initial recanalization is successful, defined by stable culprit lesion and ≥ TIMI-2 flow and no major complications (detailed below).
• Exclusion Criteria:
• • Pre-Procedure
• • 1. Previous coronary artery bypass graft surgery
• • 2. Previous anterior wall MI
• • 3. Electrophysiology electrode in the coronary sinus (ICD, CRT)
• • 4. History of stroke, transient ischemic attack, or any reversible ischemic neurological disease within the last 6 months
• • 5. Pre-MI symptoms of CHF or known LVEF of \<30%
• • 6. Pre-MI-Known anemia (Hb \<10).
• • 7. Pre-MI Known severe renal failure (eGFR \< 30 ml/min/1.73m2) or history of dialysis or renal transplant
• • 8. Unconscious status
• • 9. Contraindications to anticoagulant therapy, including hemorrhagic diathesis or thrombocytopenia
• • 10. Pregnant women
• • 11. Life expectancy \< 1 year
• • 12. Use of oral anticoagulant which is expected to be active at presentation.
• • 13. Contraindications to adenosine
• • 14. Hemodynamic instability, including pulmonary edema, cardiogenic shock
• • 15. Current participation in other investigational device or drug trials that have not completed the primary efficacy endpoint follow-up parameters
• • 16. Physician discretion that the patient should not be enrolled Intra-procedural
• • 17. Coronary sinus anatomy which precludes patient from participation in the study
• • 18. Hemodynamic instability, including cardiogenic shock or treatment with inotropes or vasopressors before, or during the PCI
• • 19. Pulmonary edema
• • 20. Acute complications of the MI
• • 21. Complication of the PCI
• • 22. Any medical condition that may be associated with a reduced prognosis