Refractory AnginaReducerNCT01566175
Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization
A study testing Neovac coronary sinus reducer in people with Refractory Angina, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial summary
The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, 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?
- Neovac coronary sinus reducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- 30 Aug 2011to 31 Dec 2031
- 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
- >18 years old
- Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
- Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine
- Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect
Who cannot join
- Recent (within three months) acute coronary syndrome
- Recent (within six months) 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 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 as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
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- 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
- Known allergy to stainless steel or nickel
- 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 implantation> 12mm
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Shmuel Banai, Prof., 972-3-6973395
Gad Keren, Prof., 972-3-6974762
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Shmuel Banai, Prof, 972-3-6973395, shmuelb@tlvmc.gov.il
About this study
Official title: Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Angina Class 3-4 Who Are Not Candidates for Revascularization
The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.
Read the detailed description
- Interventional, Allocation: Open label, Primary Purpose: Treatment
- Diagnosis and treatment for which the device is required:Patients with advanced obstructive coronary artery disease and severe disabling refractory angina despite optimal medical therapy. No revascularization option available.
- Why this unlicensed device is chosen over a licensed device or conventional therapies for this particular patient? Patient currently treated with optimal medical therapies that include: long acting nitrates, beta blockers, and calcium channel blockers. The patient is not amendable to re-do bypass graft surgery, not amendable to percutaneous coronary intervention, as determined by recent coronary angiography.
There is no other licensed device that can effectively ameliorate refractory angina and reduce the number of angina episodes and improve quality of life.
-The current device has been used in 25 patients to date. Safety information at 6 months had been published (JACC 2007;49:1783). Extended safety and efficacy information at 3 years had been reported in March 2010 (ACC Annual Scientific conference). The device has not been associated with any procedure-related adverse events during the follow-up period.
Risks (theoretical):•Coronary sinus dissection at the time of implantation. •Coronary sinus perforation and acute cardiac tamponade requiring drainage. •Device migration and embolization. •Late coronary sinus occlusion These risk were not reported in patients who receieved the device. Benefits: •Reduce angina severity. •Improve quality of life. •Reduction in the intensity of medical therapy with decrease side effects. •Reduced incidence of hospital admissions, emergency room visits and outpatient clinic visits for refractory angina. •Improved left ventricular function, and reduced LV end diastolic pressure. These patients have poor quality of life. They are disable and unable to work or to perform basic daily activities. Cannulation of the coronary sinus presents procedural risks similar to that of pacemaker electrode insertion, a procedure which is frequently performed in Interventional cardiology. For these particular patients with poor quality of life, the offered technology can potentially make them more active, more productive, and less dependent on medication and the health system.
- Conditions
- Refractory Angina
- Being tested
- Neovac coronary sinus reducer
- Keywords
- Neovasc Reducer, Coronary Sinus, Refractory Angina Pectoris, angina class 3-4
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovac coronary sinus reducerDevice
Also called Reducer
reducer
| Study group | Role | What they receive |
|---|---|---|
| Neovasc coronary sinus reducer | Experimental | open label: Neovasc coronary sinus reducer Receives: Device: Neovac coronary sinus reducer |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study start30 Aug 2011
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory AnginaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Shockwave Medical, Inc.
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566175
- Sponsor's protocol ID
- Neovasc Reducer
- Acronym
- Reducer
- Status last verified
- Feb 2022
- First submitted
- 27 Mar 2012
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Angina Class 3-4 Who Are Not Candidates for Revascularization
- ClinicalTrials.gov ID
- NCT01566175
- Acronym / sponsor ID
- Reducer / Neovasc Reducer
- Conditions
- Refractory Angina
- Keywords
- Neovasc Reducer, Coronary Sinus, Refractory Angina Pectoris, angina class 3-4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Shockwave Medical, Inc.
- Study start
- 30 Aug 2011 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 Mar 2012 (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 implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.
Detailed description
- Interventional, Allocation: Open label, Primary Purpose: Treatment
- Diagnosis and treatment for which the device is required:Patients with advanced obstructive coronary artery disease and severe disabling refractory angina despite optimal medical therapy. No revascularization option available.
- Why this unlicensed device is chosen over a licensed device or conventional therapies for this particular patient? Patient currently treated with optimal medical therapies that include: long acting nitrates, beta blockers, and calcium channel blockers. The patient is not amendable to re-do bypass graft surgery, not amendable to percutaneous coronary intervention, as determined by recent coronary angiography.
There is no other licensed device that can effectively ameliorate refractory angina and reduce the number of angina episodes and improve quality of life.
-The current device has been used in 25 patients to date. Safety information at 6 months had been published (JACC 2007;49:1783). Extended safety and efficacy information at 3 years had been reported in March 2010 (ACC Annual Scientific conference). The device has not been associated with any procedure-related adverse events during the follow-up period.
Risks (theoretical):•Coronary sinus dissection at the time of implantation. •Coronary sinus perforation and acute cardiac tamponade requiring drainage. •Device migration and embolization. •Late coronary sinus occlusion These risk were not reported in patients who receieved the device. Benefits: •Reduce angina severity. •Improve quality of life. •Reduction in the intensity of medical therapy with decrease side effects. •Reduced incidence of hospital admissions, emergency room visits and outpatient clinic visits for refractory angina. •Improved left ventricular function, and reduced LV end diastolic pressure. These patients have poor quality of life. They are disable and unable to work or to perform basic daily activities. Cannulation of the coronary sinus presents procedural risks similar to that of pacemaker electrode insertion, a procedure which is frequently performed in Interventional cardiology. For these particular patients with poor quality of life, the offered technology can potentially make them more active, more productive, and less dependent on medication and the health system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neovasc coronary sinus reducer | Experimental | Device: Neovac coronary sinus reduceropen label: Neovasc 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 (4 listed)
- >18 years old
- Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
- Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine
- Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect
Key exclusion criteria (11 listed)
- Recent (within three months) acute coronary syndrome
- Recent (within six months) 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 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 |
|---|---|---|
| Neovac coronary sinus reducerAlso: Reducerreducer | Device | Neovasc coronary sinus reducer |
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
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 2 Feb 2022.
Related trials for Refractory Angina
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REDUCER-I: An Observational Study of the Neovasc Reducer™ System
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Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
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Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
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Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neovac coronary sinus reducer in people with Refractory Angina, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
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 4 inclusion and 11 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 2 Feb 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 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?
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 Shmuel Banai, Prof. (972-3-6973395, shmuelb@tasmc.health.gov.il), or a site near the patient. 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?
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 2 Feb 2022.