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Clinical trialNCT05557019UnknownInterventional

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

SponsorIntratech Medical Ltd.Enrollment20STEMI - ST Elevation Myocardial Infarction
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Georgia
  • Israeli-Georgian Medical Research Clinic Helsicore

    Tbilisi, Georgia

    Recruiting
Israel
  • Haemek Medical Center

    Afula, Israel

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2022
Primary completion
30 Sept 2023
Completion
31 Oct 2023
Last update posted
29 Sept 2022
Registered enrollment
20
Registry id
NCT05557019
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.