NCT05557019

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 18, 2022

Last Update Submit

September 28, 2022

Conditions

STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Serious Adverse Events rate

    Device or procedure related SAEs through hospital discharge

    30 days

Study Arms (1)

Booster Balloon Therapy

EXPERIMENTAL

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.

Device: Booster Balloon Catheter

Interventions

Booster Balloon CatheterDEVICE

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.

Booster Balloon Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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).

You may not qualify if:

  • Pre-Procedure
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 52948, Georgia

RECRUITING

Haemek Medical center

Afula, 1834111, Israel

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Giora Weisz, MD

    STUDY DIRECTOR

Central Study Contacts

Hilla Ben Ezra

CONTACT

+972-52-6511131hillabenezra@gmail.com

Tsachi Doner

CONTACT

+972-52-6547755tsachi@intratechmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2022

First Posted

September 27, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GE(1)IL(1)