Clinical trial NCT01205893: Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA
Official title: Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Refractory Angina
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.


Eligibility criteria: Inclusion Criteria:

1. Patient is older than 18 years of age
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:

1. Recent (within three months) acute coronary syndrome
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

Primary outcomes:
measure: Canadian Cardiovascular Society Angina Score
timeFrame: 6 months
Secondary outcomes:
measure: Technical success
timeFrame: 24 hours
measure: Procedural success
timeFrame: 24 hours
measure: Periprocedural Serious Adverse Event:
timeFrame: 30 days
measure: Periprocedural Serious Adverse Event
timeFrame: 30 days
measure: Major Adverse Events
timeFrame: 6 months
measure: Canadian Cardiovascular Society Angina Score
timeFrame: 6 months
measure: Dobutamine Echo Wall Motion Score Index
timeFrame: 6 months
measure: Seattle Angina Questionnaire Score
timeFrame: 6 months
measure: Exercise Tolerance Testing
timeFrame: 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim Hospital
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Kristianstad
country: Sweden
facility: Central Hospital Kristianstad
city: Bradford
country: United Kingdom
facility: Royal Infirmary of Bradford
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: London
country: United Kingdom
facility: King 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: 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.
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: 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.