Refractory AnginaPhase 2COSIRANCT01205893
Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA
A Phase 2 study testing Neovasc Reducer in people with Refractory Angina, run by Shockwave Medical, Inc. at 11 sites in 6 countries.
Trial summary
The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Angina
- What is being tested?
- Neovasc Reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Sep 2010to Nov 2013
- Phase
- Phase 2
- 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
- Patient is older than 18 years of age
- Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
- Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
- Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
- Left ventricular ejection fraction greater than 25%
- Male or non-pregnant female (NB: Females of child bearing potential must have a negative pregnancy test)
- Patient understands the nature of the procedure and provides written informed consent prior to enrollment
- Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
Who cannot join
- Recent (within three months) acute coronary syndrome
- Recent (within six months) successful PCI or CABG
- Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
- De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
- Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
- Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
Show all 19Show fewer
- Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina
- Severe valvular heart disease
- Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
- Patient having undergone tricuspid valve replacement or repair
- Chronic renal failure (serum creatinine >2 mg/dL), including patients on chronic hemodialysis
- Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
- Contraindication to required study medications that cannot be adequately controlled with pre-medication
- Known allergy to stainless steel or nickel
- Contraindication to having an MRI performed (NB: Cardiac MRI subset patients only)
- Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- Mean right atrial pressure higher than or equal to 15 mmHg
- Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as:
- Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or; CS diameter at the site of planned reducer implantation less than 9.5 mm or greater than 13 mm
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United Kingdom4 sites
Royal Infirmary of Bradford
Bradford
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
King College Hospital
London, SE5 9RS
Royal Brompton Hospital
London, SW3 6NP
Belgium2 sites
ZNA Middelheim Hospital
Antwerp, 2020
Ziekenhuis Oost-Limburg
Genk, 3600
Canada2 sites
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
About this study
Official title: Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.
- Conditions
- Refractory Angina
- Being tested
- Neovasc Reducer, Control
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovasc ReducerDevice
Implantation of the Reducer
ControlDevice
Control - No device implanted
| Study group | Role | What they receive |
|---|---|---|
| Reducer | Experimental | Implant Reducer Receives: Device: Neovasc Reducer |
| Control | Sham comparator | No treatment Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Cardiovascular Society Angina Score
A decrease of two or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups
Measured: 6 months
Secondary outcomes (9)
Technical success
Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator
Measured: 24 hours
Procedural success
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
Measured: 24 hours
Periprocedural Serious Adverse Event:
A composite of death, myocardial infarction, cardiac tamponade, clinically-driven re-dilation of a failed Reducer, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the Reducer group.
Measured: 30 days
Periprocedural Serious Adverse Event
A composite of death, myocardial infarction, cardiac tamponade, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the control group.
Measured: 30 days
Major Adverse Events
A composite of cardiac death, major stroke, and myocardial infarction in the Reducer and Control groups through hospital discharge, and at six-month post-procedural evaluations.
Measured: 6 months
Canadian Cardiovascular Society Angina Score
A decrease one or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups
Measured: 6 months
Dobutamine Echo Wall Motion Score Index
Wall motion score index in both the Reducer and control groups at baseline and six-month post-procedural evaluation
Measured: 6 months
Seattle Angina Questionnaire Score
Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation
Measured: 6 months
Exercise Tolerance Testing
Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation
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 posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Refractory AnginaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Verheye, MD, Principal investigator, ZNA Middelheim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205893
- Sponsor's protocol ID
- #REDCLN-178
- Acronym
- COSIRA
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jolicoeur EM, Verheye S, Henry TD, Joseph L, Doucet S, White CJ, Edelman E, Banai S. A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina. Heart. 2021 Jan;107(1):41-46. doi: 10.1136/heartjnl-2020-316644. Epub 2020 Jul 21.
PubMed 32719097Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.
PubMed 25651246Jolicoeur EM, Banai S, Henry TD, Schwartz M, Doucet S, White CJ, Edelman E, Verheye S. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials. 2013 Feb 15;14:46. doi: 10.1186/1745-6215-14-46.
PubMed 23413981
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
- ClinicalTrials.gov ID
- NCT01205893
- Acronym / sponsor ID
- COSIRA / #REDCLN-178
- Conditions
- Refractory Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Sep 2010 (estimated)
- 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 purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reducer | Experimental | Device: Neovasc ReducerImplant Reducer |
| Control | Sham comparator | Device: ControlNo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is older than 18 years of age
- Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
- Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
- Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
- Left ventricular ejection fraction greater than 25%
Key exclusion criteria (19 listed)
- Recent (within three months) acute coronary syndrome
- Recent (within six months) successful PCI or CABG
- Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
- De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
- Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
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 |
|---|---|---|
| Neovasc ReducerImplantation of the Reducer | Device | Reducer |
| ControlControl - No device implanted | Device | Control |
Primary outcome
Canadian Cardiovascular Society Angina Score
Time frame: 6 months
A decrease of two or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups
9 secondary outcomes
Technical success
Time frame: 24 hours
Procedural success
Time frame: 24 hours
Periprocedural Serious Adverse Event:
Time frame: 30 days
Periprocedural Serious Adverse Event
Time frame: 30 days
Major Adverse Events
Time frame: 6 months
Canadian Cardiovascular Society Angina Score
Time frame: 6 months
Dobutamine Echo Wall Motion Score Index
Time frame: 6 months
Seattle Angina Questionnaire Score
Time frame: 6 months
Exercise Tolerance Testing
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 32719097Jolicoeur EM, Verheye S, Henry TD, Joseph L, Doucet S, White CJ, Edelman E, Banai S. A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina. Heart. 2021 Jan;107(1):41-46. doi: 10.1136/heartjnl-2020-316644. Epub 2020 Jul 21.
- Derived from this study: PubMed 25651246Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.
- Derived from this study: PubMed 23413981Jolicoeur EM, Banai S, Henry TD, Schwartz M, Doucet S, White CJ, Edelman E, Verheye S. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials. 2013 Feb 15;14:46. doi: 10.1186/1745-6215-14-46.
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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.
Stefan Verheye, MD principal investigator
ZNA Middelheim Hospital
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neovasc Reducer in people with Refractory Angina, run by Shockwave Medical, Inc. at 11 sites in 6 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Belgium, Canada, Denmark, Netherlands and 1 more country. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Cardiovascular Society Angina Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205893, which also lists 3 linked publications.
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 25 Nov 2013.