Skip to content

REDUCER-I: An Observational Study of the Neovasc Reducer™ System

Active, not recruitingNCT02710435
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.

Study details

Official title
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Conditions
Interventions
  • Device: Reducer System
Sponsor
Shockwave Medical, Inc.
Start date
2016-03
Primary completion
2023-11
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Total sites listed
25

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria - ALL Arms: * 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 Inclusion Criteria - Arm 1: * 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% * Male or non-pregnant female Inclusion Criteria - Arm 2: * Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study Inclusion Criteria - Arm 3: * Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study Exclusion Criteria - Arm 1: * 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 * 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…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02710435