An observational study in Angina Pectoris, Angina Pectoris, Stable and Chronic Stable Angina, sponsored by Shockwave Medical, Inc.. Active, not recruiting at 25 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Shockwave Medical, Inc. · Observational
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
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).
519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.
This study's planned enrollment of 400 is below the median of 591 across 154 observational studies indexed under Angina Pectoris.
Browse Angina Pectoris studies →Shockwave Medical, Inc. is the lead sponsor of 28 studies on the registry; 4 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria - ALL Arms:
Inclusion Criteria - Arm 1:
Inclusion Criteria - Arm 2:
Inclusion Criteria - Arm 3:
Exclusion Criteria - Arm 1:
Angiographic Exclusion:
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
Device: Reducer System
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
Device: Reducer System
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
Device: Reducer System
An aid in the management of chronic refractory angina pectoris
Also known as: Reducer
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
Time frame: 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
Time frame: 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
Time frame: 30 days post implant
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
Time frame: 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
Time frame: 6 months, 12 months, and annually through 5 years
Change in Exercise Tolerance Test (ETT) Parameters
The change in ETT parameters at 6 and 12 months post implant as compared to baseline: Total exercise duration (min), Time to 1mm ST-Segment Depression (min), METs, Double Product by ETT
Time frame: 6 and 12 months
Improvement in Quality of Life (QoL
Improvement in QoL scores at 6 months, 12 months and annually through 5 years post implant as compared to baseline
Time frame: 6 months, 12 months, and annually through 5 years
Reduction in Emergency Department Visits
Reduction in documented Emergency Department visits due to angina episodes at 12 months post implant as compared to 12 months prior to implantation of the Reducer
Time frame: 12 months
Reduction in Angina Medication
Reduction in angina medication use at 6 months, 12 months and annually through 5 years post implant as compared to baseline
Time frame: 6 months, 12 months, and annually through 5 years
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shockwave Medical, Inc.