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

NCT05557019 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-09-29

No results posted yet for this study

Summary

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.

Conditions

  • STEMI - ST Elevation Myocardial Infarction

Interventions

DEVICE

Booster Balloon Catheter

The Booster balloon therapy (i.e. partial occlusion of the CS lumen with a subsequent backward pressure elevation without obstructing the CS blood flow) will start immediately after a successful PCI of the culprit coronary lesion in the LAD, with TIMI-II flow restoration. The Booster balloon therapy will then be continued for up to 90 min, but not less than 60 min.

Sponsors & Collaborators

  • Intratech Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Giora Weisz, MD

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-09-30
Completion
2023-10-31

Countries

  • Georgia
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05557019 on ClinicalTrials.gov