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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Booster Balloon Catheter

About this trial

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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
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

Sites / Locations

Israeli-Georgian Medical Research Clinic HelsicoreRecruiting
Haemek Medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Booster Balloon Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Serious Adverse Events rate

Device or procedure related SAEs through hospital discharge

Secondary Outcome Measures

Full Information

NCT ID

NCT05557019

First Posted

September 18, 2022

Last Updated

September 28, 2022

Sponsor

Intratech Medical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05557019

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intratech Medical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

STEMI - ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Booster Balloon Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Booster Balloon Catheter

Intervention Description

Primary Outcome Measure Information:

Title

Serious Adverse Events rate

Description

Device or procedure related SAEs through hospital discharge

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hilla Ben Ezra

Phone

+972-52-6511131

hillabenezra@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tsachi Doner

Phone

+972-52-6547755

tsachi@intratechmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giora Weisz, MD

Official's Role

Study Director

Facility Information:

Facility Name

Israeli-Georgian Medical Research Clinic Helsicore

City

Tbilisi

ZIP/Postal Code

52948

Country

Georgia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irakli Gogorishvili, MD

Phone

+995 32 243 33 43

Facility Name

Haemek Medical center

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoav Turgeman, MD

Phone

+972-52-2827195

yoav_t@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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