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
Sponsored by
About this trial
This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
Intervention Name(s)
Booster Balloon Catheter
Intervention 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.
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
No
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
Email
hillabenezra@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tsachi Doner
Phone
+972-52-6547755
Email
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
Email
yoav_t@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
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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