Angina With No Obstructive Coronary Artery DiseaseREDUCE-ANOCANCT07010029
Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease
A study testing Coronary Sinus Reducer in people with Angina With No Obstructive Coronary Artery Disease and ANOCA, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Even half of patients with angina undergoing invasive coronary angiography presents without any significant epicardial stenosis. In these cases, symptoms are usually caused by coronary microvascular dysfunction (CMD), developing as a result of several potential underlying pathophysiologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina With No Obstructive Coronary Artery Disease, ANOCA, Coronary Sinus Reducer
- 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
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 12 May 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Stable angina symptoms without significant obstruction of coronary artery (defined as coronary artery stenosis diameter ≤ 50% or coronary artery stenosis diameter >50% and ≤70% with FFR>0.8), with coronary microvascular dysfunction confirmed in invasive test (defined as coronary flow reserve ≤ 2.5 or index of microvascular resistance ≥ 25)
- No future options for antianginal therapy (maximum antianginal therapy for at least three months)
Who cannot join
- Vasospastic angina (positive test with acetylcholine),
- Evidence of cardiac ischemia,
- Coronary flow limiting myocardial bridge,
- Severe valvular disease
- Hospitalization for acute heart failure < 3 months
- Hypertrophic cardiomyopathy,
Show all 15Show fewer
- Ejection fraction ≤ 30%,
- Permanent pacemaker or defibrillator leads in the right heart,
- Recent acute coronary syndrome < 6 months,
- Recent revascularization < 2 months,
- Right atrial pressure of 15 mmHg or higher,
- Severe renal impairment,
- Indication for cardiac resynchronization therapy,
- Pregnancy,
- Life expectancy of less than 1 year,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adrian Bednarek contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, 02-091
Mariusz Tomaniak, Professor, +48 22 5991951, mariusz.tomaniak@wum.edu.pl
About this study
Official title: Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease: a Prospective Single-arm Study
Even half of patients with angina undergoing invasive coronary angiography presents without any significant epicardial stenosis. In these cases, symptoms are usually caused by coronary microvascular dysfunction (CMD), developing as a result of several potential underlying pathophysiologies. A wide range of underlying pathomechanisms makes it challenging to develop molecular-targeted pharmacological solutions; thus, direct physiology modification has been introduced as a promising concept. The coronary sinus reducer (CSR) narrows the coronary sinus, which causes symptom relief in patients with refractory angina and coronary stenosis. CSR implantation aims to increase the coronary sinus pressure, which raises venous back pressure into the myocardium. Despite several hypotheses, the exact physiological mechanisms remain not fully elucidated. Recent data from observational studies also suggest the beneficial effect of CMD on microvascular indices. To date, there are limited data regarding the efficacy of this solution in patients with angina with no obstructive coronary artery disease (ANOCA). Of note, patients with ANOCA are frequently burdened with other comorbidities, such as heart failure with preserved ejection fraction (HFpEF). HFpEF presence relates to worse prognosis and higher risk of future cardiovascular events. Previous works showed that HFpEF is significantly associated with the appearance of CMD. Due to the small variety of drugs for HFpEF, treatment targeting CMD may be a promising therapeutic target for this disease. To date, there is also no data regarding the impact of CSR implantation on function of left ventricle and echocardiographic indexes impaired in diastolic dysfunction in patients with ANOCA. Proposed study aims to evaluate the CSR as a therapeutic strategy in patients with ANOCA to improve angina, as well as quality of life and will deliver the results regarding CSR impact on diastolic function of left and right ventricle. This study will also evaluate the mechanisms standing behind the benefits of CSR use. Neovasc reducer produced by Shockwave Medical inc will be used as CSR device in this study. Proposed study may lead to the introduction of the Neovasc reducer to the guidelines for ANOCA patients. It will also provide the data on Neovasc reducer potential use as a supportive therapy in patients with HFpEF. Prospective, single-arm cohort study including patients with angina with no obstructive coronary artery disease. Enrolled patients will undergo the Neovasc reducer implantation with periprocedural evaluation of coronary microcirculation before and directly after the device implantation. All patients will be assessed with echocardiography (evaluation by external corelab) at baseline and at six months of follow-up. Patients will also undergo exercise testing (six-minute walk test) and assessment of quality of life (SF-36), as well as angina severity (Seattle Angina Questionnaire, Dedicated app and Canadian Cardiovascular Society grade).
- Being tested
- Coronary Sinus Reducer
- Keywords
- CFR, IMR, Angina, ANOCA, CSR, Coronary Sinus Reducer, Diastolic Dysfunction, Quality of Life, FFR
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Sinus ReducerDevice
Patients will undergo implantation of Coronary Sinus Reducer
| Study group | Role | What they receive |
|---|---|---|
| Coronary Sinus Reducer | Experimental | Patients will undergo implantation of Coronary Sinus Reducer Receives: Device: Coronary Sinus Reducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical endpoint - Difference in summary Seattle Angina Questionnaire results between follow-up and baseline
The Seattle Angina Questionnaire (SAQ) is measured on a scale of 0 to 100 - higher scores represent better outcomes.
Measured: 6 months
Mechanical endpoint - difference in left ventricle global longitudinal strain between follow-up and baseline
Left ventricle global longitudinal strain will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Secondary outcomes (16)
Difference in Coronary Flow Reserve measured directly post-procedure and pre-procedure
Measured: Peri-procedural
Difference in Index of Microcirculatory Resistance and Resistance measured directly post-procedure and pre-procedure
Measured: Peri-procedural
Difference in Microvascular Resistance Reserve measured directly post-procedure and pre-procedure
Microvascular Resistance Reserve will be assessed as the ratio of true resting to hyperemic microvascular resistance measured with thermodilution
Measured: Peri-procedural
Difference in Canadian Cardiovascular Society Class between follow-up and baseline
The Canadian Cardiovascular Society (CCS) classification ranges from Class I to IV - higher classes indicate more severe angina.
Measured: 6 months
Difference in each Seattle Angina Questionnaire domain between follow-up and baseline
The Seattle Angina Questionnaire (SAQ) is measured on a scale of 0 to 100 - higher scores represent better outcomes.
Measured: 6 months
Difference in Short Form-36 Health Survey results between follow-up and baseline
The Short Form-36 (SF-36) Health Survey is scored on a scale from 0 to 100 - higher scores indicate better health status and quality of life.
Measured: 6 months
Difference in six-minute walk test between follow-up and baseline
Measured: 6 months
Difference in right ventricle four chamber longitudinal strain between follow-up and baseline
Measured: 6 months
Difference in left atrial strain conduit (%) between follow-up and baseline
Left atrial strain conduit (measured in %) will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Difference in left atrial strain pump (%) between follow-up and baseline
Left atrial strain pump (measured in %) will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Difference in left atrial strain reservoir (%) between follow-up and baseline
Left atrial strain pump (measured in %) will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Difference in average E/e' ratio between follow-up and baseline
Measured: 6 months
Difference in E (m/s) between follow-up and baseline
The parameter of mitral inflow (E - m/s) will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Difference in lateral, septal and average e' (cm/s) between follow-up and baseline
The e' (cm/s) will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Difference in Tricuspid Annular Plane Systolic Excursion between follow-up and baseline
Tricuspid Annular Plane Systolic Excursion (mm) will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
Measured: 6 months
Difference in RV S' (cm/s) between follow-up and baseline
RV S' (measured in cm/s) will be assessed with echocardiography. Measurements will be performed according to the current guidelines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start12 May 2025
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina With No Obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Prospective, single-arm cohort study including patients with angina with no obstructive coronary artery disease. Enrolled patients will undergo the Neovasc reducer implantation with periprocedural evaluation of coronary microcirculation (continous thermodilution) before and directly after the device implantation. All patients will be assessed with echocardiography (evaluation by external corelab) at baseline and at six months of follow-up. Patients will also undergo exercise testing (six-minute walk test) and assessment of quality of life (SF-36), as well as angina severity (Seattle Angina Questionnaire, Dedicated app and Canadian Cardiovascular Society grade). Patients will also undergo the prolonged two-years follow-up (long term follow-up) regarding angina severity and QoL to evaluate the persistence of the effect - those outcomes will be included in separate analysis.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Tomaniak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010029
- Sponsor's protocol ID
- REDUCE-ANOCA
- Acronym
- REDUCE-ANOCA
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease: a Prospective Single-arm Study
- ClinicalTrials.gov ID
- NCT07010029
- Acronym / sponsor ID
- REDUCE-ANOCA / REDUCE-ANOCA
- Keywords
- CFR, IMR, Angina, ANOCA, CSR, Coronary Sinus Reducer, Diastolic Dysfunction, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Jun 2025 (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.
Even half of patients with angina undergoing invasive coronary angiography presents without any significant epicardial stenosis. In these cases, symptoms are usually caused by coronary microvascular dysfunction (CMD), developing as a result of several potential underlying pathophysiologies. A wide range of underlying pathomechanisms makes it challenging to develop molecular-targeted pharmacological solutions; thus, direct physiology modification has been introduced as a promising concept. The coronary sinus reducer (CSR) narrows the coronary sinus, which causes symptom relief in patients with refractory angina and coronary stenosis. CSR implantation aims to increase the coronary sinus pressure, which raises venous back pressure into the myocardium. Despite several hypotheses, the exact physiological mechanisms remain not fully elucidated. Recent data from observational studies also suggest the beneficial effect of CMD on microvascular indices. To date, there are limited data regarding the efficacy of this solution in patients with angina with no obstructive coronary artery disease (ANOCA). Of note, patients with ANOCA are frequently burdened with other comorbidities, such as heart failure with preserved ejection fraction (HFpEF). HFpEF presence relates to worse prognosis and higher risk of future cardiovascular events. Previous works showed that HFpEF is significantly associated with the appearance of CMD. Due to the small variety of drugs for HFpEF, treatment targeting CMD may be a promising therapeutic target for this disease. To date, there is also no data regarding the impact of CSR implantation on function of left ventricle and echocardiographic indexes impaired in diastolic dysfunction in patients with ANOCA. Proposed study aims to evaluate the CSR as a therapeutic strategy in patients with ANOCA to improve angina, as well as quality of life and will deliver the results regarding CSR impact on diastolic function of left and right ventricle. This study will also evaluate the mechanisms standing behind the benefits of CSR use. Neovasc reducer produced by Shockwave Medical inc will be used as CSR device in this study. Proposed study may lead to the introduction of the Neovasc reducer to the guidelines for ANOCA patients. It will also provide the data on Neovasc reducer potential use as a supportive therapy in patients with HFpEF. Prospective, single-arm cohort study including patients with angina with no obstructive coronary artery disease. Enrolled patients will undergo the Neovasc reducer implantation with periprocedural evaluation of coronary microcirculation before and directly after the device implantation. All patients will be assessed with echocardiography (evaluation by external corelab) at baseline and at six months of follow-up. Patients will also undergo exercise testing (six-minute walk test) and assessment of quality of life (SF-36), as well as angina severity (Seattle Angina Questionnaire, Dedicated app and Canadian Cardiovascular Society grade).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm cohort study including patients with angina with no obstructive coronary artery disease. Enrolled patients will undergo the Neovasc reducer implantation with periprocedural evaluation of coronary microcirculation (continous thermodilution) before and directly after the device implantation. All patients will be assessed with echocardiography (evaluation by external corelab) at baseline and at six months of follow-up. Patients will also undergo exercise testing (six-minute walk test) and assessment of quality of life (SF-36), as well as angina severity (Seattle Angina Questionnaire, Dedicated app and Canadian Cardiovascular Society grade). Patients will also undergo the prolonged two-years follow-up (long term follow-up) regarding angina severity and QoL to evaluate the persistence of the effect - those outcomes will be included in separate analysis.
| Arm | Type | Receives |
|---|---|---|
| Coronary Sinus Reducer | Experimental | Device: Coronary Sinus ReducerPatients will undergo implantation of Coronary Sinus Reducer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable angina symptoms without significant obstruction of coronary artery (defined as coronary artery stenosis diameter ≤ 50% or coronary artery stenosis diameter >50% and ≤70% with FFR>0.8), with coronary microvascular dysfunction confirmed in invasive test (defined as coronary flow reserve ≤ 2.5 or index of microvascular resistance ≥ 25)
- No future options for antianginal therapy (maximum antianginal therapy for at least three months)
Key exclusion criteria (15 listed)
- Vasospastic angina (positive test with acetylcholine),
- Evidence of cardiac ischemia,
- Coronary flow limiting myocardial bridge,
- Severe valvular disease
- Hospitalization for acute heart failure < 3 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 |
|---|---|---|
| Coronary Sinus ReducerPatients will undergo implantation of Coronary Sinus Reducer | Device | Coronary Sinus Reducer |
Primary outcome
Clinical endpoint - Difference in summary Seattle Angina Questionnaire results between follow-up and baseline
Time frame: 6 months
The Seattle Angina Questionnaire (SAQ) is measured on a scale of 0 to 100 - higher scores represent better outcomes.
Mechanical endpoint - difference in left ventricle global longitudinal strain between follow-up and baseline
Time frame: 6 months
Left ventricle global longitudinal strain will be assessed with echocardiography. Measurements will be performed according to the current guidelines.
16 secondary outcomes
Difference in Coronary Flow Reserve measured directly post-procedure and pre-procedure
Time frame: Peri-procedural
Difference in Index of Microcirculatory Resistance and Resistance measured directly post-procedure and pre-procedure
Time frame: Peri-procedural
Difference in Microvascular Resistance Reserve measured directly post-procedure and pre-procedure
Time frame: Peri-procedural
Difference in Canadian Cardiovascular Society Class between follow-up and baseline
Time frame: 6 months
Difference in each Seattle Angina Questionnaire domain between follow-up and baseline
Time frame: 6 months
Difference in Short Form-36 Health Survey results between follow-up and baseline
Time frame: 6 months
Difference in six-minute walk test between follow-up and baseline
Time frame: 6 months
Difference in right ventricle four chamber longitudinal strain between follow-up and baseline
Time frame: 6 months
Difference in left atrial strain conduit (%) between follow-up and baseline
Time frame: 6 months
Difference in left atrial strain pump (%) between follow-up and baseline
Time frame: 6 months
Difference in left atrial strain reservoir (%) between follow-up and baseline
Time frame: 6 months
Difference in average E/e' ratio between follow-up and baseline
Time frame: 6 months
Difference in E (m/s) between follow-up and baseline
Time frame: 6 months
Difference in lateral, septal and average e' (cm/s) between follow-up and baseline
Time frame: 6 months
Difference in Tricuspid Annular Plane Systolic Excursion between follow-up and baseline
Time frame: 6 months
Difference in RV S' (cm/s) between follow-up and baseline
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- 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.
Adrian Bednarek contact
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 Angina With No Obstructive Coronary Artery Disease and ANOCA, run by Medical University of Warsaw at 1 site in Poland.
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 15 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: looking for participants now, as of the sponsor's last update on 8 Jun 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariusz Tomaniak, Professor (+48 22 5991951, mariusz.tomaniak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical endpoint - Difference in summary Seattle Angina Questionnaire results between follow-up and baseline (time frame: 6 months). The study lists 2 primary outcomes in all. 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 8 Jun 2025; AzTrials last refreshed its copy on 4 Nov 2026.