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

NCT ID: NCT05557019

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-10-31

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Booster Balloon Therapy

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.

Group Type: EXPERIMENTAL

Booster Balloon Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Pre procedural:

1. Age above 18 years of age

2. 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)

3. STEMI culprit lesion in LAD

4. < 24-hour duration from time of symptom onset until admission to the emergency room

5. Patient providing informed consent compatible with the requirement of the institutional ethical committee.

6. Patient and physician agree to all required follow-up procedures and visits

7. Coronary sinus diameter of 10 mm

8. PCI is indicated for culprit lesion in the LAD with planned use of a stent

9. Initial recanalization is successful, defined by stable culprit lesion and ≥ TIMI-2 flow and no major complications (detailed below).

Exclusion Criteria

Pre-Procedure

1. Previous coronary artery bypass graft surgery

2. Previous anterior wall MI

3. Electrophysiology electrode in the coronary sinus (ICD, CRT)

4. History of stroke, transient ischemic attack, or any reversible ischemic neurological disease within the last 6 months

5. Pre-MI symptoms of CHF or known LVEF of <30%

6. Pre-MI-Known anemia (Hb <10).

7. Pre-MI Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal transplant

8. Unconscious status

9. Contraindications to anticoagulant therapy, including hemorrhagic diathesis or thrombocytopenia

10. Pregnant women

11. Life expectancy < 1 year

12. Use of oral anticoagulant which is expected to be active at presentation.

13. Contraindications to adenosine

14. Hemodynamic instability, including pulmonary edema, cardiogenic shock

15. Current participation in other investigational device or drug trials that have not completed the primary efficacy endpoint follow-up parameters

16. Physician discretion that the patient should not be enrolled Intra-procedural

17. Coronary sinus anatomy which precludes patient from participation in the study

18. Hemodynamic instability, including cardiogenic shock or treatment with inotropes or vasopressors before, or during the PCI

19. Pulmonary edema

20. Acute complications of the MI

21. Complication of the PCI

22. Any medical condition that may be associated with a reduced prognosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intratech Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giora Weisz, MD

Role: STUDY_DIRECTOR

Locations

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, , Georgia

Site Status: RECRUITING

Haemek Medical center

Afula, , Israel

Site Status: RECRUITING

Countries

Georgia; Israel

Central Contacts

Hilla Ben Ezra

Role: CONTACT

hillabenezra@gmail.com

+972-52-6511131

Tsachi Doner

Role: CONTACT

tsachi@intratechmedical.com

+972-52-6547755

Facility Contacts

Irakli Gogorishvili, MD

Role: primary

+995 32 243 33 43

Yoav Turgeman, MD

Role: primary

yoav_t@clalit.org.il

+972-52-2827195

Other Identifiers

CLD-002

Identifier Type: -

Identifier Source: org_study_id