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

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02710435
• Other study ID #: 022-REDUCLN-001
• Status: Active, not recruiting
• Start date: March 2016
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: Neovasc Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2028
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Stable
• Angina, Stable
• Chronic Stable Angina

Intervention

Device:
• Reducer System
An aid in the management of chronic refractory angina pectoris

Locations

Country	Name	City	State
Austria	University of Graz	Graz
Belgium	ZNA Middelheim Hospital	Antwerpen
Belgium	Zienkenhuis Oost-Limburg	Genk
France	University Hospital of Brest	Brest
France	Institut Coeur Poumon	Lille
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Dresden University	Dresden
Germany	Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik f?r Kardiologie und Angiologie	Essen
Germany	University Heart Center Freiburg - Bad Krozingen	Freiburg
Germany	University Giessen	Giessen
Germany	University Heart Center Hamburg	Hamburg
Italy	San Raffaele Hospital	Milan
Italy	Bolognini General Hospital	Seriate
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	UMC Utrecht	Utrecht
Spain	Hospital Clinico San Carlos	Madrid
Switzerland	University Hospital Basel	Basel
Switzerland	HFR Fribourg/University of Fribourg	Fribourg
Switzerland	Hopitaux Universitaires Geneve (HUG)	Geneva
Switzerland	Istituto Cardiocentro Ticino	Lugano
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	King's College Hospital	London
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St. Thomas Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Neovasc Inc.	Shockwave Medical, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

References & Publications (7)

Abawi 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. — View Citation

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. — View Citation

Banai 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. — View Citation

Konigstein 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. — View Citation

Konigstein 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. — View Citation

Verheye 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. — View Citation

Verheye 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	6 and 12 months
Other	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	6 months, 12 months, and annually through 5 years
Other	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	12 months
Other	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	6 months, 12 months, and annually through 5 years
Primary	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	6 Months
Primary	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	30 days post implant
Primary	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	30 days post implant
Secondary	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	12 months and annually through 5 years
Secondary	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	6 months, 12 months, and annually through 5 years

External Links

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