STEMI - ST Elevation Myocardial InfarctionNCT05557019
Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study
A study testing Booster Balloon Catheter in people with STEMI - ST Elevation Myocardial Infarction, run by Intratech Medical Ltd. at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Booster Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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%
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Georgia1 site, 1 recruiting
- Recruiting
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, 52948
Irakli Gogorishvili, MD, +995 32 243 33 43
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical center
Afula, 1834111
Yoav Turgeman, MD, +972-52-2827195, yoav_t@clalit.org.il
About this study
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.
Read the 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.
- Being tested
- Booster Balloon Catheter
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Booster Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events rate
Device or procedure related SAEs through hospital discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intratech Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giora Weisz, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557019
- Sponsor's protocol ID
- CLD-002
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study
- ClinicalTrials.gov ID
- NCT05557019
- Acronym / sponsor ID
- CLD-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Intratech Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Booster Balloon Therapy | Experimental | Device: Booster Balloon CatheterThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Booster Balloon CatheterThe 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 Therapy |
Primary outcome
Serious Adverse Events rate
Time frame: 30 days
Device or procedure related SAEs through hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giora Weisz, MD study director
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booster Balloon Catheter in people with STEMI - ST Elevation Myocardial Infarction, run by Intratech Medical Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilla Ben Ezra (+972-52-6511131, hillabenezra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.