Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II (COSIRA-II)

  • STATUS
    Recruiting
  • End date
    Dec 19, 2028
  • participants needed
    380
  • sponsor
    Neovasc Inc.
Updated on 7 October 2022

Summary

To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm will further assess the safety and effectiveness of the Neovasc Reducer System in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects with reversible myocardial ischemia without documented obstructive coronary disease and subjects who cannot complete an exercise tolerance test due to an above-the-ankle amputation.

Description

The COSIRA-II study is a multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial.

Details
Condition Refractory Angina
Treatment Arm 1: treatment with Neovasc Reducer, Arm 2 (control): Implantation procedure with no device implanted, Arm 3 (unblinded, non-randomized): Single arm registry
Clinical Study IdentifierNCT05102019
SponsorNeovasc Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject must meet all inclusion and exclusion criteria for the main randomized trial
except for three possible specific conditions as follows
Subjects with evidence of either exercise or pharmacologically induced reversible
ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFRCT, FFR
iFR, or other non-hyperemic FDA approved or cleared tests in the predominate (RCA >
LCA ischemia) or sole distribution of the right coronary artery
Subjects with evidence of either exercise or pharmacologically induced reversible
ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, CFR, or IMR
without documented obstructive coronary disease (i.e. estimated diameter stenosis in
all coronary lesions is <50%)
Subjects who are unable to complete the required COSIRA-II exercise tolerance test due
to lower limb amputation (above the ankle)
Single-Arm Registry Angiographic Inclusion Criteria
Obstructive CAD: Three-vessel coronary angiography performed within the 12 months
prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis
of ≥70%) in the RCA if it is single vessel disease, or the ischemia in the territory
of the RCA is greater than the ischemia in the territory of the LCA when it is >2
vessel coronary disease, or a fractional flow reserve (FFR) value of ≤0.80 or an iFR
(or other FDA-approved/cleared non-hyperemic physiologic assessment) of ≤0.89 in an
RCA lesion with a visually assessed diameter stenosis of ≥50% in single RCA coronary
disease, that is not suitable for and will not be treated with PCI or CABG as
determined by the local heart team
Non-obstructive CAD: Patients with non-obstructive CAD (coronary narrowing of <50%
and/or FFR ≥0.81) Note: The qualifying 3-vessel angiogram must be performed after any
myocardial infarction or CABG within the 12 months prior to enrollment. For patients
with multiple 3-vessel angiograms, the one performed closest to enrollment will serve
as the qualifying study

Exclusion Criteria

Severe valvular heart disease (any valve)
Moderate or severe RV dysfunction by echocardiography
Pacemaker electrode/lead is present in the coronary sinus
Known allergy to stainless steel or nickel
Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary
syndrome (NSTEMI or STEMI)
Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may
still be enrolled
Recent successful revascularization by either CABG or PCI within six months prior to
enrollment Note: Successful revascularization is defined as any CABG procedure, or any
Comorbidities limiting life expectancy to less than one year
PCI procedure with a reduction of one or more lesions to <50% diameter stenosis
Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion)
within 30 days prior to enrollment
The predominant manifestation of angina is dyspnea. Note: some dyspnea may be present
with exertion, but the predominant symptom that limits activity must be angina (i.e
chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation
to the neck, jaw, shoulders, arms, or other location)
Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism
anemia (hgb <10 g/dL), uncontrolled hypertension (systolic blood pressure >160 mmHg or
diastolic blood pressure >100 mmHg despite medications), atrial fibrillation with
rapid ventricular response (consistently >100 bpm despite medications) or other
tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left
ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric
left ventricular hypertrophy is not an exclusion criterion)
NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF
during the 90 days prior to enrollment
Life threatening rhythm disorders or any rhythm disorders that would require future
placement of an internal defibrillator and/or pacemaker
Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced
expiratory volume in one second (FEV1) that is less than 55% of the predicted value
or need for home daytime oxygen or oral steroids
A Class I indication is present for an implantable defibrillator or cardiac
resynchronization therapy according to ACCF/AHA/HRS guidelines
Recent implantation of a new pacemaker or defibrillator lead with electrode in the
right atrium within 90 days of enrollment
Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD
formula) or subjects on chronic dialysis
Any clinical condition that might interfere with the trial protocol or the subject's
ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse
dementia, magnetic resonances imaging (MRI) planned within 8 weeks of randomization.)
Currently enrolled in another investigational device or drug trial that has not
reached its primary endpoint or that might clinically interfere with the current trial
endpoints or procedures
Pregnant or planning pregnancy within the next 12 months (women of reproductive
potential must have a negative pregnancy test within 7 days of the randomization
procedure)
Subject is part of a vulnerable population who, in the judgment of the investigator
is unable to give Informed Consent for reasons of incapacity, immaturity, adverse
personal circumstances or lack of autonomy. This may include individuals with mental
disability, persons in nursing homes, children, impoverished persons, persons in
emergency situations, homeless persons, nomads, refugees, and those incapable of
giving informed consent. Vulnerable populations also may include members of a group
with a hierarchical structure such as university students, subordinate hospital and
laboratory personnel, employees of the Sponsor, members of the armed forces, and
persons kept in detention
Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral
anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on
a chronic oral anticoagulant
Subject is currently hospitalized for definite or suspected COVID-19
Subject has previously been symptomatic with or hospitalized for COVID-19 and has been
asymptomatic for <8 weeks prior to enrollment or has not returned to his or her prior
baseline (pre-COVID-19) clinical condition
Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within
the past 4 weeks prior to enrollment
Angiographic/Hemodynamic Exclusion Criteria
) Coronary anatomy amenable to revascularization of ischemic myocardial territory by
either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or
angina equivalent symptoms, as per the assessment of the local heart team
Note: If a pathway to coronary revascularization is present which, in the opinion of the
local heart team, is reasonably low risk and reasonably likely to provide long-term symptom
relief and the subject refuses the revascularization procedure, the patient is ineligible
for randomization
Procedural Angiographic/Hemodynamic Randomization Exclusion Criteria
Mean right atrial pressure greater than 15 mmHg assessed during the final screening
procedure for eligibility assessment and potential randomization
Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left
superior vena cava [SVC]) as demonstrated by angiogram
The CS diameter at the most proximal end of the planned implant region (2-4 cm distal
to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm
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