Coronary Artery DiseaseNCT06266065
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia
A study testing Coronary Sinus Reducer in people with Coronary Artery Disease and Angina Pectoris, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial summary
The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Coronary Sinus Reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCroatia
- Study dates
- 27 Feb 2024to Jun 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
- Signed informed consent
Who cannot join
- Severely reduced systolic ejection fraction of the left ventricle (EF < 35 %)
- Severe renal impairment (eGFR < 30ml/min/1.73m2)
- Severe chronic obstructive pulmonary disease (GOLD D)
- Contraindication for application of papaverine or regadenoson
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Centre Zagreb
Zagreb, 10000
Josko Bulum, MD, PhD, +385981714090, jbulum@gmail.com
Luka Percin, MD, +385917917252, luka.percin555@gmail.com
About this study
Official title: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris
The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter < 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- Coronary Sinus Reducer
- Keywords
- Coronary Sinus Reducer, Myocardial Ischemia, Coronary Microcirculation
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Sinus ReducerDevice
Implantation of Coronary Sinus Reducer
| Study group | Role | What they receive |
|---|---|---|
| Coronary Sinus Reducer | Experimental | Not described Receives: Device: Coronary Sinus Reducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Coronary Sinus Reducer on Coronary Microcirculation
Assessment of Coronary Flow Reserve and Index of Microcirculatory Resistance before and after Coronary Sinus Reducer implantation
Measured: 2 and half years
Secondary outcomes (3)
Myocardial Ischemia assessment
Evaluation of the ischemic zone before and 6 months after the procedure using Perfusion Stress Cardiac Magnetic Resonance
Measured: 2 and half years
Angina assessment
Comparison of the severity of angina pectoris before and 6 months after the procedure using the Canadian Cardiovascular Society angina scale (CCS) and the Seattle Angina Questionnaire-7 (SAQ-7).
Measured: 2 and half years
Functional capacity assessment
Assessment of functional capacity before and 6 months after the procedure through 6 Minute Walk Test
Measured: 2 and half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start27 Feb 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Model description
- Single-Center Prospective Study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josko Bulum, MD, PhD, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266065
- Sponsor's protocol ID
- 8.1-23/260-2;02/013AG
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris
- ClinicalTrials.gov ID
- NCT06266065
- Acronym / sponsor ID
- 8.1-23/260-2;02/013AG
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Coronary Sinus Reducer, Myocardial Ischemia, Coronary Microcirculation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Feb 2024 (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 increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter < 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Center Prospective Study
| Arm | Type | Receives |
|---|---|---|
| Coronary Sinus Reducer | Experimental | Device: Coronary Sinus Reducer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization
- Signed informed consent
Key exclusion criteria (4 listed)
- Severely reduced systolic ejection fraction of the left ventricle (EF < 35 %)
- Severe renal impairment (eGFR < 30ml/min/1.73m2)
- Severe chronic obstructive pulmonary disease (GOLD D)
- Contraindication for application of papaverine or regadenoson
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 |
|---|---|---|
| Coronary Sinus ReducerImplantation of Coronary Sinus Reducer | Device | Coronary Sinus Reducer |
Primary outcome
Impact of Coronary Sinus Reducer on Coronary Microcirculation
Time frame: 2 and half years
Assessment of Coronary Flow Reserve and Index of Microcirculatory Resistance before and after Coronary Sinus Reducer implantation
3 secondary outcomes
Myocardial Ischemia assessment
Time frame: 2 and half years
Angina assessment
Time frame: 2 and half years
Functional capacity assessment
Time frame: 2 and half years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Sinus Reducer in people with Coronary Artery Disease and Angina Pectoris, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
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 2 inclusion and 4 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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 Josko Bulum, MD, PhD (+385981714090, jbulum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Coronary Sinus Reducer on Coronary Microcirculation (time frame: 2 and half years). 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 6 Mar 2024.