Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02710435
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Neovasc Inc.

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

Condition or disease Intervention/treatment
Angina Pectoris Angina Pectoris, Stable Chronic Stable Angina Device: Neovasc Reducer System

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Other
Official Title: REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Study Start Date : March 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Group/Cohort Intervention/treatment
Arm 1 - Prospective
Includes eligible subjects in the prospective arm who undergo baseline testing followed by the Neovasc Reducer System implant procedure
Device: Neovasc Reducer System
An aid in the management of chronic refractory angina pectoris
Other Name: Reducer

Arm 2 - COSIRA
Includes subjects who were previously enrolled and treated with the Neovasc Reducer System during the COSIRA study and agree to participate in this long term follow up study
Device: Neovasc Reducer System
An aid in the management of chronic refractory angina pectoris
Other Name: Reducer

Arm 3 - CE Mark

Includes subjects who received a Neovasc 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: Neovasc Reducer System
An aid in the management of chronic refractory angina pectoris
Other Name: Reducer




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Reduction in Canadian Cardiovascular Society (CCS) Grade [ Time Frame: 12 months and annually through 5 years ]
    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

  2. Occurrence of Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months, 12 months, and annually through 5 years ]
    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


Other Outcome Measures:
  1. Change in Exercise Tolerance Test (ETT) Parameters [ Time Frame: 6 and 12 months ]
    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

  2. Improvement in Quality of Life (QoL [ Time Frame: 6 months, 12 months, and annually through 5 years ]
    Improvement in QoL scores at 6 months, 12 months and annually through 5 years post implant as compared to baseline

  3. Reduction in Emergency Department Visits [ Time Frame: 12 months ]
    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

  4. Reduction in Angina Medication [ Time Frame: 6 months, 12 months, and annually through 5 years ]
    Reduction in angina medication use at 6 months, 12 months and annually through 5 years post implant as compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710435


Contacts
Layout table for location contacts
Contact: Karen A Cook 855.802.5180 ext 307 kcook@neovasc.com
Contact: Sarah Gallagher 855.802.5180 ext 300 sgallagher@neovasc.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Neovasc Inc.
Investigators
Layout table for investigator information
Principal Investigator: Stefan Verheye, MD ZNA Middelheim Hospital
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Neovasc Inc.
ClinicalTrials.gov Identifier: NCT02710435    
Other Study ID Numbers: 022-REDUCLN-001
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neovasc Inc.:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations