Coronary Microvascular DiseaseCOSIMANCT04606459
COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
A study testing Coronary sinus reducer and Optimal medical therapy in people with Coronary Microvascular Disease and Refractory Angina, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Microvascular Disease, Refractory Angina
- What is being tested?
- Coronary sinus reducer and Optimal medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 20 Oct 2029
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤85 years
- Chronic coronary syndrome (including patients with anginal equivalents) refractory angina CCS class III-IV despite guideline-directed medical therapy
- Evidence of reversible ischemia on non-invasive testing
- Evidence of microvascular disease as diagnosed invasively by at least one of the following:
- index of microvascular resistances (IMR) >25 and/or
- coronary flow reserve (CFR) <2.0) with fractional flow reserve (FFR)>0.8.
- Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial.
Who cannot join
- Subjects presenting at least one of the following criteria will not be enrolled in the trial
- Recent (within 3 months) acute coronary syndrome
- Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG)
- Recent (within 30 days) unsuccessful PCI
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
- Left ventricular ejection fraction of <30%
Show all 20Show fewer
- Mean right atrial pressure >15mmHg
- Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) as demonstrated by angiogram
- CS diameter at the site of planned Reducer implantation greater than 13mm or less than 9.5mm as measured by angiogram
- Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
- Severe valvular heart disease
- A pacemaker electrode in the coronary sinus
- Tricuspid valve replacement or repair
- Chronic renal failure (serum creatinine >2mg/dL), and/or on chronic hemodialysis
- Moribund, or with comorbidities limiting life expectancy to less than one year
- Known severe reaction to required procedural medications
- Known allergy to stainless steel or nickel
- Need for Magnetic Resonance Imaging (MRI) within 8 weeks after reducer implantation
- Contraindication to dual antiplatelet therapy
- Female of childbearing potential (last menstruation within the last 12 months or who did not undergo tubal ligation, ovariectomy or hysterectomy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, 55131
Tommaso Gori, Prof Dr, PhD, +49 (0) 6131 17 2729, tommaso.gori@unimedizin-mainz.de
Tommaso Gori, Prof Dr, PhD
About this study
Official title: A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer as Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.
Read the detailed description
Recent data show that 47% of the patients undergoing coronary angiography for angina have no epicardial disease. Of these, 52% have isolated microvascular angina, 17% have isolated vasospastic angina, 20% have both, and 11% have non-cardiac chest pain. These data suggest that microvascular disease is a highly prevalent condition, which might affect as many as 25% of all patients undergoing coronary angiography (without counting patients with acute coronary syndromes and those with mixed epicardial and microvascular disease). Based on an estimate of the Woman´s Ischemia Syndrome Evaluation (WISE) study, 3-4 million patients with symptoms of myocardial ischemia have non-obstructive coronary artery disease in the United States of America. These patients represent a significant burden in terms of mortality and morbidity as well as in terms of healthcare costs due to disability, hospitalization, and repeat testing.
Patients with microvascular angina require frequent hospitalizations, undergo repeat invasive procedures, have an impaired quality of life and a poor prognosis, since patients with a high index of microvascular resistances) have a higher risk of mortality (hazard ratio (HR) 1.6[0.8-3.4], P<0.001)). An analysis of the WISE study identified an impaired coronary flow reserve in the absence of epicardial disease as the strongest predictor of 5-year adverse events (26.7% versus 12.2%, HR 1.2[1.1.-1.4], P=0.008).
Although its importance is acknowledged by the most recent guidelines, microvascular angina represents a major clinical challenge. In particular, there is a strong disagreement on its classification, on the several mechanisms behind its pathophysiology, and the therapeutic alternatives available remain unsatisfactory.
Despite these uncertainties, there is a consensus that this condition is highly frequent, as it affects up to two-thirds of patients who suffer from stable angina and either have no coronary stenoses at angiography or have combined epicardial and microvascular disease.
The limits of medical therapy Traditional anti-ischaemic drugs are the first step in medical treatment, but their effectiveness is very limited in the setting of microvascular disease. Short-acting nitrates can be used to treat anginal attacks, but since nitrates are only effective on large arteries, this therapy is only indicated for the therapy of patients whose symptoms are caused by spasm of epicardial coronaries, and not for true microvascular angina. Beta-blockers limit myocardial oxygen consumption but do not affect the mechanisms of microvascular disease. Calcium antagonists, have shown variable results in clinical trials, but the limitation of this approach is that a significant heterogeneity exists in the types of calcium channels in the vasculature.
Evidence on the coronary sinus reducer In recent years, the coronary sinus reducer has been introduced to treat refractory angina in patients with refractory angina due to obstructive coronary artery disease (CAD) and no revascularization options, a situation similar to microvascular disease. This novel therapy is based on the concept that an elevation in backward pressure in the coronary venous system provokes dilatation of the subendocardial arterioles, resulting in a significant reduction of vascular resistance in this area and a redistribution of blood flow to these ischaemic subendocardial layers. Numerous studies confirm the efficacy of the Reducer for patients suffering from angina who are not candidates for revascularization. Preliminary evidence supporting the use of this device in microvascular disease patients also exists, but requires confirmation in a large, randomized trial.
- Conditions
- Coronary Microvascular Disease, Refractory Angina
- Being tested
- Coronary sinus reducer, Optimal medical therapy
- Medical subject headings
- Microvascular Angina, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary sinus reducerDevice
The Reducer System comprises the Reducer device (Reducer) pre-mounted on the Reducer Balloon Catheter. The Reducer System is available in one model size. The Reducer is a sterile, single-use, implantable device designed to establish a narrowing in the coronary sinus (CS) and is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina. The device is implanted percutaneously through the right internal jugular vein into the CS. The Reducer is pre-mounted (crimped) on the Reducer Balloon Catheter which, after inflation, causes device expansion and apposition with the vessel wall. The balloon catheter is then deflated and removed from the CS, leaving the device permanently implanted.
Optimal medical therapyOther
Guideline-directed medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Optimal medical therapy | Active comparator | Optimal medical therapy consisting of acetyl salicylic acid, statins, beta-blockers, calcium channel-antagonists, ranolazine will be administered at the discretion of the physician as recommended by the most recent European Society of Cardiology (ESC) guidelines.
Long-acting nitrates will not be administered unless for patients with fractional flow reserve (FFR)<0.8 or with previously reported good response. Short-acting nitrates may be administered in patients in whom concomitant epicardial spasm is suspected, but they have no documented effect on microvascular angina. Receives: Other: Optimal medical therapy |
| Coronary sinus reducer | Experimental | The device being studied is the Neovasc Reducer™ System. Each patient in the Reducer group will be implanted with a single Reducer according to the instructions for use. Receives: Device: Coronary sinus reducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Cardiovascular Society angina class by two or more classes
Proportion of patients improving ≥2 CCS angina classes at six months after the implantation followed byoptimal medical therapy (OMT) compared to OMT alone.
Measured: 6 months
Secondary outcomes (11)
Change in angina severity according to the Seattle Angina Questionnaire
change in angina severity as assessed by the Seattle Angina Questionnaire (SAQ-7, range from 0 to 100, with 100 as minimal physical limitation and angina and 0 as maximal limitation and angina) at six months.
Measured: Six months
Number of participants with technical success
- Technical success: in the Reducer group, defined as successful delivery and deployment of the Reducer to the intended site as assessed by the investigator
Measured: Implantation day
Procedural success
- Procedural success: in the Reducer group, defined as technical success and the absence of acute need for clinically-driven intervention to address an Adverse or Serious Adverse Device Effect prior to hospital discharge, as adjudicated by the Clinical Events Committee (CEC)
Measured: Implantation day
Frequency of use of sublingual nitrates (times per week)
Use of sublingual nitrates
Measured: 6 months, 1 year, 5 years
Parameters of angina and quality of life
Seattle Angina Questionnaire:
- SAQ-7 Physical limitation scale
- SAQ-7 angina stability scale
- SAQ-7 angina frequency scale
- SAQ-7 quality of life
- SAQ-7 Treatment Satisfaction
- Disease perception scale
Measured: at 6 months
Incidence of adverse events
Combined incidence of :
Death (all cause and cardiovascular) Myocardial infarction Revascularization Periprocedural complications
Measured: 5 years
Number of documented Emergency Department (ED) visits due to angina episodes
Number of documented Emergency Department (ED) visits due to angina episodes
Measured: 6 and 12 months
Canadian Cardiovascular Society angina class
CCS Angina class
Measured: 6 months, 1 year, 5 years
Number of unplanned hospitalizations for cardiac ischemia, angina or anginal equivalent, heart failure
Unplanned hospitalization for cardiac ischemia, angina or anginal equivalent, heart failure
Measured: 6 months, 1 year, 5 years
Change in 5-level EQ-5D version (EQ-5D-5L)
5-level EQ-5D version (EQ-5D-5L, EuroQol Group) change in visual score, from 0 to 100 (best)
Measured: 6 months
Beck depression inventory
Beck depression inventory, from 1 (best) to 40 (worst)
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 posted28 Oct 2020
- Study start1 Apr 2021
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the current randomized, controlled, parallel-groups trial, patients will be randomized to guideline-directed optimal medical therapy with coronary sinus Reducer (Neovasc Reducer™ System) implantation or guideline-directed medical therapy alone.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Principal investigator, Tommaso Gori, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606459
- Sponsor's protocol ID
- 2020-15363
- Acronym
- COSIMA
- Status last verified
- Sep 2023
- First submitted
- 18 Oct 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon motivated request all data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer as Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina
- ClinicalTrials.gov ID
- NCT04606459
- Acronym / sponsor ID
- COSIMA / 2020-15363
- Conditions
- Coronary Microvascular Disease, Refractory Angina
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2029 (estimated)
- First posted
- 28 Oct 2020 (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.
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.
Detailed description
Recent data show that 47% of the patients undergoing coronary angiography for angina have no epicardial disease. Of these, 52% have isolated microvascular angina, 17% have isolated vasospastic angina, 20% have both, and 11% have non-cardiac chest pain. These data suggest that microvascular disease is a highly prevalent condition, which might affect as many as 25% of all patients undergoing coronary angiography (without counting patients with acute coronary syndromes and those with mixed epicardial and microvascular disease). Based on an estimate of the Woman´s Ischemia Syndrome Evaluation (WISE) study, 3-4 million patients with symptoms of myocardial ischemia have non-obstructive coronary artery disease in the United States of America. These patients represent a significant burden in terms of mortality and morbidity as well as in terms of healthcare costs due to disability, hospitalization, and repeat testing.
Patients with microvascular angina require frequent hospitalizations, undergo repeat invasive procedures, have an impaired quality of life and a poor prognosis, since patients with a high index of microvascular resistances) have a higher risk of mortality (hazard ratio (HR) 1.6[0.8-3.4], P<0.001)). An analysis of the WISE study identified an impaired coronary flow reserve in the absence of epicardial disease as the strongest predictor of 5-year adverse events (26.7% versus 12.2%, HR 1.2[1.1.-1.4], P=0.008).
Although its importance is acknowledged by the most recent guidelines, microvascular angina represents a major clinical challenge. In particular, there is a strong disagreement on its classification, on the several mechanisms behind its pathophysiology, and the therapeutic alternatives available remain unsatisfactory.
Despite these uncertainties, there is a consensus that this condition is highly frequent, as it affects up to two-thirds of patients who suffer from stable angina and either have no coronary stenoses at angiography or have combined epicardial and microvascular disease.
The limits of medical therapy Traditional anti-ischaemic drugs are the first step in medical treatment, but their effectiveness is very limited in the setting of microvascular disease. Short-acting nitrates can be used to treat anginal attacks, but since nitrates are only effective on large arteries, this therapy is only indicated for the therapy of patients whose symptoms are caused by spasm of epicardial coronaries, and not for true microvascular angina. Beta-blockers limit myocardial oxygen consumption but do not affect the mechanisms of microvascular disease. Calcium antagonists, have shown variable results in clinical trials, but the limitation of this approach is that a significant heterogeneity exists in the types of calcium channels in the vasculature.
Evidence on the coronary sinus reducer In recent years, the coronary sinus reducer has been introduced to treat refractory angina in patients with refractory angina due to obstructive coronary artery disease (CAD) and no revascularization options, a situation similar to microvascular disease. This novel therapy is based on the concept that an elevation in backward pressure in the coronary venous system provokes dilatation of the subendocardial arterioles, resulting in a significant reduction of vascular resistance in this area and a redistribution of blood flow to these ischaemic subendocardial layers. Numerous studies confirm the efficacy of the Reducer for patients suffering from angina who are not candidates for revascularization. Preliminary evidence supporting the use of this device in microvascular disease patients also exists, but requires confirmation in a large, randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the current randomized, controlled, parallel-groups trial, patients will be randomized to guideline-directed optimal medical therapy with coronary sinus Reducer (Neovasc Reducer™ System) implantation or guideline-directed medical therapy alone.
| Arm | Type | Receives |
|---|---|---|
| Optimal medical therapy | Active comparator | Other: Optimal medical therapyOptimal medical therapy consisting of acetyl salicylic acid, statins, beta-blockers, calcium channel-antagonists, ranolazine will be administered at the discretion of the physician as recommended by the most recent European Society of Cardiology (ESC) guidelines. Long-acting nitrates will not be administered unless for patients with fractional flow reserve (FFR)<0.8 or with previously reported good response. Short-acting nitrates may be administered in patients in whom concomitant epicardial spasm is suspected, but they have no documented effect on microvascular angina. |
| Coronary sinus reducer | Experimental | Device: Coronary sinus reducerThe device being studied is the Neovasc Reducer™ System. Each patient in the Reducer group will be implanted with a single Reducer according to the instructions for use. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤85 years
- Chronic coronary syndrome (including patients with anginal equivalents) refractory angina CCS class III-IV despite guideline-directed medical therapy
- Evidence of reversible ischemia on non-invasive testing
- Evidence of microvascular disease as diagnosed invasively by at least one of the following:
- Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial.
Key exclusion criteria (20 listed)
- Subjects presenting at least one of the following criteria will not be enrolled in the trial
- Recent (within 3 months) acute coronary syndrome
- Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG)
- Recent (within 30 days) unsuccessful PCI
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 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 reducerThe Reducer System comprises the Reducer device (Reducer) pre-mounted on the Reducer Balloon Catheter. The Reducer System is available in one model size. The Reducer is a sterile, single-use, implantable device designed to establish a narrowing in the coronary sinus (CS) and is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina. The device is implanted percutaneously through the right internal jugular vein into the CS. The Reducer is pre-mounted (crimped) on the Reducer Balloon Catheter which, after inflation, causes device expansion and apposition with the vessel wall. The balloon catheter is then deflated and removed from the CS, leaving the device permanently implanted. | Device | Coronary sinus reducer |
| Optimal medical therapyGuideline-directed medical therapy | Other | Optimal medical therapy |
Primary outcome
Change in Canadian Cardiovascular Society angina class by two or more classes
Time frame: 6 months
Proportion of patients improving ≥2 CCS angina classes at six months after the implantation followed byoptimal medical therapy (OMT) compared to OMT alone.
11 secondary outcomes
Change in angina severity according to the Seattle Angina Questionnaire
Time frame: Six months
Number of participants with technical success
Time frame: Implantation day
Procedural success
Time frame: Implantation day
Frequency of use of sublingual nitrates (times per week)
Time frame: 6 months, 1 year, 5 years
Parameters of angina and quality of life
Time frame: at 6 months
Incidence of adverse events
Time frame: 5 years
Number of documented Emergency Department (ED) visits due to angina episodes
Time frame: 6 and 12 months
Canadian Cardiovascular Society angina class
Time frame: 6 months, 1 year, 5 years
Number of unplanned hospitalizations for cardiac ischemia, angina or anginal equivalent, heart failure
Time frame: 6 months, 1 year, 5 years
Change in 5-level EQ-5D version (EQ-5D-5L)
Time frame: 6 months
Beck depression inventory
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 28 Sep 2023.
- Individual participant dataSharing planned: Undecided. Upon motivated request all data will be shared
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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.
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 and Optimal medical therapy in people with Coronary Microvascular Disease and Refractory Angina, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 7 inclusion and 20 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 28 Sep 2023. 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 Germany. 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 tommaso gori, PI (+496131172829, tommaso.gori@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Cardiovascular Society angina class by two or more classes (time frame: 6 months). 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 28 Sep 2023.