Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA
NCT ID: NCT01205893
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2010-09-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Reducer
Implant Reducer
Neovasc Reducer
Implantation of the Reducer
Control
No treatment
Control
Control - No device implanted
Interventions
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Neovasc Reducer
Implantation of the Reducer
Control
Control - No device implanted
Eligibility Criteria
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Inclusion Criteria
2. Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
3. Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
4. Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
5. Left ventricular ejection fraction greater than 25%
6. Male or non-pregnant female (NB: Females of child bearing potential must have a negative pregnancy test)
7. Patient understands the nature of the procedure and provides written informed consent prior to enrollment
8. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
Exclusion Criteria
2. Recent (within six months) successful PCI or CABG
3. Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
4. De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
5. Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
6. 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
7. Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina
8. Severe valvular heart disease
9. Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
10. Patient having undergone tricuspid valve replacement or repair
11. Chronic renal failure (serum creatinine \>2 mg/dL), including patients on chronic hemodialysis
12. Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
13. Contraindication to required study medications that cannot be adequately controlled with pre-medication
14. Known allergy to stainless steel or nickel
15. Contraindication to having an MRI performed (NB: Cardiac MRI subset patients only)
16. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
17. Mean right atrial pressure higher than or equal to 15 mmHg
18. Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as:
Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or; CS diameter at the site of planned reducer implantation less than 9.5 mm or greater than 13 mm
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan Verheye, MD
Role: PRINCIPAL_INVESTIGATOR
ZNA Middelheim Hospital
Locations
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ZNA Middelheim Hospital
Antwerp, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Rigshospitalet
Copenhagen, , Denmark
UMC Utrecht
Utrecht, , Netherlands
Central Hospital Kristianstad
Kristianstad, , Sweden
Royal Infirmary of Bradford
Bradford, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
King College Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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Jolicoeur EM, Verheye S, Henry TD, Joseph L, Doucet S, White CJ, Edelman E, Banai S. A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina. Heart. 2021 Jan;107(1):41-46. doi: 10.1136/heartjnl-2020-316644. Epub 2020 Jul 21.
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.
Jolicoeur EM, Banai S, Henry TD, Schwartz M, Doucet S, White CJ, Edelman E, Verheye S. A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial. Trials. 2013 Feb 15;14:46. doi: 10.1186/1745-6215-14-46.
Other Identifiers
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#REDCLN-178
Identifier Type: -
Identifier Source: org_study_id