RecruitingNot ApplicableNCT01566175

Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization

Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Angina Class 3-4 Who Are Not Candidates for Revascularization

Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

100 participants

Start Date

Aug 30, 2011

Study Type

INTERVENTIONAL

Conditions

Refractory Angina

Summary

The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

\>18 years old
Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine
Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect

Exclusion Criteria11

Recent (within three months) acute coronary syndrome
Recent (within six months) PCI or CABG
Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
De-compensated congestive heart failure or hospitalization due to CHF during the three months prior to screening
Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
Severe chronic obstructive pulmonary disease as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
Severe valvular heart disease
Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
Patient having undergone tricuspid valve replacement or repair
Known allergy to stainless steel or nickel
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 implantation\> 12mm

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