NCT01566175 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
| NCT ID | NCT01566175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Condition | Refractory Angina |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2011-08-30 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2011-08-30 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * \>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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT01566175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01566175 currently recruiting?
Yes, NCT01566175 is actively recruiting participants. Contact the research team at shmuelb@tasmc.health.gov.il for enrollment information.
Where is the NCT01566175 trial being conducted?
This trial is being conducted at Tel Aviv, Israel, Tel Aviv, Israel.
Who is sponsoring the NCT01566175 clinical trial?
NCT01566175 is sponsored by Tel-Aviv Sourasky Medical Center. The trial plans to enroll 100 participants.