Angina PectorisNCT02710435
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
An observational study of Angina Pectoris and Angina Pectoris, Stable, run by Shockwave Medical, Inc. at 25 sites in 9 countries.
Trial summary
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Angina Pectoris, Stable, Chronic Stable Angina
- What is being tested?
- Reducer System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 25 sitesin 9 countries
- Study dates
- Mar 2016to Dec 2028
- Phase
- Observational
- 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
Study population: Subjects with refractory angina pectoris who demonstrate objective evidence of reversible myocardial ischemia, who have limited or no options for revascularization, or subjects who have received the Reducer in the COSIRA study, or under CE Mark prior to the REDUCER-I study.
Who may be able to join
- Subject has been informed about the study and provides written informed consent prior to enrollment
- Subject is willing to comply with specified follow-up evaluations
- Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy
- Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)
- Evidence of reversible myocardial ischemia
- Left Ventricular ejection fraction (LVEF) greater than or equal to 30%
Show all 9Show fewer
- Male or non-pregnant female
- Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study
- Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study
Who cannot join
- Acute coronary syndrome within three months prior to enrollment
- Recent successful revascularization by PCI or CABG within six months prior to enrollment
- Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment
- Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram [ECG] changes) during the 30 days prior to enrollment
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment
- 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 22Show fewer
- Subject cannot undergo exercise tolerance test
- Subject cannot undergo 6-minute walk test
- Severe valvular heart disease
- Subject with pacemaker electrode in the coronary sinus (CS)
- Subject with recent placement of a new pacemaker or defibrillator electrode in the right atrium within 3 months prior to enrollment.
- Subject having undergone tricuspid valve replacement or repair
- Chronic renal failure (serum creatinine >2 mg/dL), including subjects on chronic hemodialysis
- Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year
- Known severe reaction to required procedural medications
- Known allergy to stainless steel or nickel
- Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation
- Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- Angiographic Exclusion:
- Mean right atrial pressure greater than 15mmHg
- Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC])
- CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
Germany6 sites
Kerckhoff Klinik
Bad Nauheim, 61231
Dresden University
Dresden, 01307
Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie
Essen, 45138
University Heart Center Freiburg - Bad Krozingen
Freiburg im Breisgau, 79106
University Giessen
Giessen, 35392
University Heart Center Hamburg
Hamburg, 20246
United Kingdom5 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
St. Thomas Hospital
London, SE1 7EH
King's College Hospital
London, SE5 9RS
Royal Brompton Hospital
London, SW3 6NP
Switzerland4 sites
University Hospital Basel
Basel, CH-4031
HFR Fribourg/University of Fribourg
Fribourg, 1708
Hopitaux Universitaires Geneve (HUG)
Geneva, 1205
Istituto Cardiocentro Ticino
Lugano, 6900
Belgium2 sites
ZNA Middelheim Hospital
Antwerp, 2020
Zienkenhuis Oost-Limburg
Genk, 3600
Italy2 sites
San Raffaele Hospital
Milan, 20132
Bolognini General Hospital
Seriate, 24068
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435CM
UMC Utrecht
Utrecht, 3584 CX
About this study
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
Read the detailed description
This study is a multicenter, multi-country three-arm prospective and retrospective investigation in up to 400 subjects conducted at a maximum of 40 investigational centers. Arm 1 will include eligible prospective subjects. Arm 2 will include subjects who were previously enrolled and treated with the Reducer during the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study. Arm 3 will include subjects who received a Reducer under CE Mark (unrelated to the COSIRA study).
- Being tested
- Reducer System
- Keywords
- Coronary Sinus, Reducer, Refractory Angina, Angina Pectoris, Angina Pectoris, Stable, Chronic Stable Angina, Persistent Angina, Neovasc Reducer System, Refractory Angina Pectoris, Coronary Sinus Narrowing, Reversible Ischemic Heart Disease, Chronic Angina, End Stage Angina, Coronary Sinus Reduction, Coronary Sinus Reducer, Chronic Refractory Angina, Chronic Refractory Angina Pectoris
- Medical subject headings
- Angina Pectoris, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducer SystemDevice
Also called Reducer
An aid in the management of chronic refractory angina pectoris
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Prospective | Includes eligible subjects in the prospective arm who undergo baseline testing followed by the Reducer System implant procedure
Arm 1 has been closed to enrollment-March 2023 Receives: Device: Reducer System | |
| Arm 2 - COSIRA | Includes subjects who were previously enrolled and treated with the Reducer System during the COSIRA study and agree to participate in this long term follow up study Receives: Device: Reducer System | |
| Arm 3 - CE Mark | Includes subjects who received a Reducer System under CE Mark (unrelated to the COSIRA study), and agree to participate in this long term follow up study
Arm 3 has been closed to enrollment-June 2017 Receives: Device: Reducer System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Canadian Cardiovascular Society (CCS) Grade
The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade, at 6 months as compared to baseline
Measured: 6 Months
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s
The rate of occurrence of device and / or procedure-related periprocedural SAEs defined as a composite of death, Myocardial Infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer, life-threatening arrhythmias (Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF)), and respiratory failure through 30 days post-implant
Measured: 30 days post implant
Occurrence of Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant
Measured: 30 days post implant
Secondary outcomes (2)
Reduction in Canadian Cardiovascular Society (CCS) Grade
The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade at 12 months and annually through 5 years post implant as compared to baseline
Measured: 12 months and annually through 5 years
Occurrence of Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI at 6 months, 12 months and annually through 5 years post implant
Measured: 6 months, 12 months, and annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2023
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
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
- NCT02710435
- Sponsor's protocol ID
- 022-REDUCLN-001
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2016
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Banai S, Ben Muvhar S, Parikh KH, Medina A, Sievert H, Seth A, Tsehori J, Paz Y, Sheinfeld A, Keren G. Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study. J Am Coll Cardiol. 2007 May 1;49(17):1783-9. doi: 10.1016/j.jacc.2007.01.061.
PubMed 17466229Banai S, Verheye S, Jolicoeur EM. A device to narrow the coronary sinus for angina. N Engl J Med. 2015 May 14;372(20):1967-8. doi: 10.1056/NEJMc1503672. No abstract available.
PubMed 25970058Verheye 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 25651246Konigstein M, Verheye S, Jolicoeur EM, Banai S. Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris. Cardiol Rev. 2016 Sep-Oct;24(5):238-43. doi: 10.1097/CRD.0000000000000101.
PubMed 26886464Abawi M, Nijhoff F, Stella PR, Voskuil M, Benedetto D, Doevendans PA, Agostoni P. Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience. Neth Heart J. 2016 Sep;24(9):544-51. doi: 10.1007/s12471-016-0862-2.
PubMed 27299456Konigstein M, Meyten N, Verheye S, Schwartz M, Banai S. Transcatheter treatment for refractory angina with the Coronary Sinus Reducer. EuroIntervention. 2014 Feb;9(10):1158-64. doi: 10.4244/EIJV9I10A196.
PubMed 24561732Verheye S, Agostoni P, Giannini F, Hill JM, Jensen C, Lindsay S, Stella PR, Redwood S, Banai S, Konigstein M. Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study). EuroIntervention. 2021 Sep 20;17(7):561-568. doi: 10.4244/EIJ-D-20-00873.
PubMed 33319762
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REDUCER-I: An Observational Study of the Neovasc Reducer™ System
- ClinicalTrials.gov ID
- NCT02710435
- Acronym / sponsor ID
- 022-REDUCLN-001
- Keywords
- Coronary Sinus, Reducer, Refractory Angina, Angina Pectoris, Angina Pectoris, Stable, Chronic Stable Angina, Persistent Angina, Neovasc Reducer System
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Nov 2023 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Mar 2016 (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 collect long term data of the Reducer System in subjects with refractory angina pectoris.
Detailed description
This study is a multicenter, multi-country three-arm prospective and retrospective investigation in up to 400 subjects conducted at a maximum of 40 investigational centers. Arm 1 will include eligible prospective subjects. Arm 2 will include subjects who were previously enrolled and treated with the Reducer during the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study. Arm 3 will include subjects who received a Reducer under CE Mark (unrelated to the COSIRA study).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Prospective | – | Device: Reducer SystemIncludes eligible subjects in the prospective arm who undergo baseline testing followed by the Reducer System implant procedure Arm 1 has been closed to enrollment-March 2023 |
| Arm 2 - COSIRA | – | Device: Reducer SystemIncludes subjects who were previously enrolled and treated with the Reducer System during the COSIRA study and agree to participate in this long term follow up study |
| Arm 3 - CE Mark | – | Device: Reducer SystemIncludes subjects who received a Reducer System under CE Mark (unrelated to the COSIRA study), and agree to participate in this long term follow up study Arm 3 has been closed to enrollment-June 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with refractory angina pectoris who demonstrate objective evidence of reversible myocardial ischemia, who have limited or no options for revascularization, or subjects who have received the Reducer in the COSIRA study, or under CE Mark prior to the REDUCER-I study.
Key inclusion criteria (9 listed)
- Subject has been informed about the study and provides written informed consent prior to enrollment
- Subject is willing to comply with specified follow-up evaluations
- Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy
- Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)
- Evidence of reversible myocardial ischemia
Key exclusion criteria (22 listed)
- Acute coronary syndrome within three months prior to enrollment
- Recent successful revascularization by PCI or CABG within six months prior to enrollment
- Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment
- Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram [ECG] changes) during the 30 days prior to enrollment
- Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment
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 |
|---|---|---|
| Reducer SystemAlso: ReducerAn aid in the management of chronic refractory angina pectoris | Device | Arm 1 - Prospective, Arm 2 - COSIRA, Arm 3 - CE Mark |
Primary outcome
Reduction in Canadian Cardiovascular Society (CCS) Grade
Time frame: 6 Months
The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade, at 6 months as compared to baseline
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s
Time frame: 30 days post implant
The rate of occurrence of device and / or procedure-related periprocedural SAEs defined as a composite of death, Myocardial Infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer, life-threatening arrhythmias (Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF)), and respiratory failure through 30 days post-implant
Occurrence of Major Adverse Cardiac Events (MACE)
Time frame: 30 days post implant
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant
2 secondary outcomes
Reduction in Canadian Cardiovascular Society (CCS) Grade
Time frame: 12 months and annually through 5 years
Occurrence of Major Adverse Cardiac Events (MACE)
Time frame: 6 months, 12 months, and annually through 5 years
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 16 Oct 2026.
- Background: PubMed 17466229Banai S, Ben Muvhar S, Parikh KH, Medina A, Sievert H, Seth A, Tsehori J, Paz Y, Sheinfeld A, Keren G. Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study. J Am Coll Cardiol. 2007 May 1;49(17):1783-9. doi: 10.1016/j.jacc.2007.01.061.
- Background: PubMed 25970058Banai S, Verheye S, Jolicoeur EM. A device to narrow the coronary sinus for angina. N Engl J Med. 2015 May 14;372(20):1967-8. doi: 10.1056/NEJMc1503672. No abstract available.
- Background: 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.
- Background: PubMed 26886464Konigstein M, Verheye S, Jolicoeur EM, Banai S. Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris. Cardiol Rev. 2016 Sep-Oct;24(5):238-43. doi: 10.1097/CRD.0000000000000101.
- Background: PubMed 27299456Abawi M, Nijhoff F, Stella PR, Voskuil M, Benedetto D, Doevendans PA, Agostoni P. Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience. Neth Heart J. 2016 Sep;24(9):544-51. doi: 10.1007/s12471-016-0862-2.
- Background: PubMed 24561732Konigstein M, Meyten N, Verheye S, Schwartz M, Banai S. Transcatheter treatment for refractory angina with the Coronary Sinus Reducer. EuroIntervention. 2014 Feb;9(10):1158-64. doi: 10.4244/EIJV9I10A196.
- Background: PubMed 33319762Verheye S, Agostoni P, Giannini F, Hill JM, Jensen C, Lindsay S, Stella PR, Redwood S, Banai S, Konigstein M. Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study). EuroIntervention. 2021 Sep 20;17(7):561-568. doi: 10.4244/EIJ-D-20-00873.
- Company product webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Angina Pectoris
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina Pectoris and Angina Pectoris, Stable, run by Shockwave Medical, Inc. at 25 sites in 9 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 9 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, United Kingdom, Switzerland, Belgium, France and 4 more countries. 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?
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?
Reduction in Canadian Cardiovascular Society (CCS) Grade (time frame: 6 Months). The study lists 3 primary outcomes in all. 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 NCT02710435, which also lists 7 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 16 Oct 2026.