Clinical trial NCT02710435: REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Official title: REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Angina Pectoris
Angina Pectoris, Stable
Chronic Stable Angina
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
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

Brief summary: 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).

Eligibility 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

Primary outcomes:
measure: Reduction in Canadian Cardiovascular Society (CCS) Grade
timeFrame: 6 Months
measure: Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s
timeFrame: 30 days post implant
measure: Occurrence of Major Adverse Cardiac Events (MACE)
timeFrame: 30 days post implant
Secondary outcomes:
measure: Reduction in Canadian Cardiovascular Society (CCS) Grade
timeFrame: 12 months and annually through 5 years
measure: Occurrence of Major Adverse Cardiac Events (MACE)
timeFrame: 6 months, 12 months, and annually through 5 years
Other outcomes:
measure: Change in Exercise Tolerance Test (ETT) Parameters
timeFrame: 6 and 12 months
measure: Improvement in Quality of Life (QoL
timeFrame: 6 months, 12 months, and annually through 5 years
measure: Reduction in Emergency Department Visits
timeFrame: 12 months
measure: Reduction in Angina Medication
timeFrame: 6 months, 12 months, and annually through 5 years
Locations:
city: Graz
country: Austria
facility: University of Graz
city: Antwerpen
country: Belgium
facility: ZNA Middelheim Hospital
city: Genk
country: Belgium
facility: Zienkenhuis Oost-Limburg
city: Brest
country: France
facility: University Hospital of Brest
city: Lille
country: France
facility: Institut Coeur Poumon
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Dresden
country: Germany
facility: Dresden University
city: Essen
country: Germany
facility: Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie
city: Freiburg
country: Germany
facility: University Heart Center Freiburg - Bad Krozingen
city: Giessen
country: Germany
facility: University Giessen
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Seriate
country: Italy
facility: Bolognini General Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Fribourg
country: Switzerland
facility: HFR Fribourg/University of Fribourg
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires Geneve (HUG)
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: ZNA Middelheim Hospital
name: Stefan Verheye, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.
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.