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

  • End date
    Oct 16, 2023
  • participants needed
  • sponsor
    Intratech Medical Ltd.
Updated on 16 October 2022


The present study is planned to evaluate the safety and feasibility of the Booster Balloon catheter when applied to STEMI patients. The Booster Balloon is a spiral balloon intended to be positioned in the coronary sinus, enabling continuous venous draining while reducing flow and increasing the pressure inside the venous capillaries, and redistributing blood and oxygen to the border zone of the ischemic myocardium. This pilot, first-in-human study is designed to evaluate (in addition to safety and feasibility) the treatment modality in the setting of acute STEMI, as adjunctive therapy after restoring blood blow through the infract-related artery.


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 study aimed to evaluate the safety and feasibility of the Booster Balloon Catheter (BBC). The study will include up to 20 patients in up to 5 centers in Israel and Europe.

After the patients sign the informed consent, all the eligibility criteria will be evaluated. If a subject is found to be ineligible, the subject will be considered a "screen failure". Subjects who meet eligibility criteria will be treated with the BBC.

The total duration of subject participation will be 30±7 days.

Condition STEMI - ST Elevation Myocardial Infarction
Treatment Booster Balloon Catheter
Clinical Study IdentifierNCT05557019
SponsorIntratech Medical Ltd.
Last Modified on16 October 2022


Yes No Not Sure

Inclusion Criteria

Pre procedural
Age above 18 years of age
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)
STEMI culprit lesion in LAD
< 24-hour duration from time of symptom onset until admission to the emergency room
Patient providing informed consent compatible with the requirement of the institutional ethical committee
Patient and physician agree to all required follow-up procedures and visits
Angiographic inclusion criteria
Coronary sinus diameter of 10 mm
PCI is indicated for culprit lesion in the LAD with planned use of a stent
Initial recanalization is successful, defined by stable culprit lesion and ≥ TIMI-2 flow and no major complications (detailed below)

Exclusion Criteria

Previous coronary artery bypass graft surgery
Previous anterior wall MI
Electrophysiology electrode in the coronary sinus (ICD, CRT)
History of stroke, transient ischemic attack, or any reversible ischemic neurological disease within the last 6 months
Pre-MI symptoms of CHF or known LVEF of <30%
Pre-MI-Known anemia (Hb <10)
Pre-MI Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant
Unconscious status
Contraindications to anticoagulant therapy, including hemorrhagic diathesis or thrombocytopenia
Pregnant women
Life expectancy < 1 year
Use of oral anticoagulant which is expected to be active at presentation
Contraindications to adenosine
Hemodynamic instability, including pulmonary edema, cardiogenic shock
Current participation in other investigational device or drug trials that have not completed the primary efficacy endpoint follow-up parameters
Physician discretion that the patient should not be enrolled Intra-procedural
Coronary sinus anatomy which precludes patient from participation in the study
Hemodynamic instability, including cardiogenic shock or treatment with inotropes or vasopressors before, or during the PCI
Pulmonary edema
Acute complications of the MI
Complication of the PCI
Any medical condition that may be associated with a reduced prognosis
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