Implanting a device to treat severe angina in patients who can't undergo surgery
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
This study is testing a new device to see if it can help people with severe chest pain who can't have surgery feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 2 sites (Tel Aviv and 1 other locations) |
| Trial ID | NCT01566175 on ClinicalTrials.gov |
What this trial studies
This study aims to implant the Neovasc Coronary Sinus Reducer in patients suffering from refractory angina pectoris, specifically those classified as CCS grade III or IV who are not candidates for revascularization. The approach involves using this unlicensed device to alleviate symptoms and improve quality of life for patients with advanced obstructive coronary artery disease despite optimal medical therapy. The study is open-label and focuses on patients who have demonstrated reversible ischemia through diagnostic tests. The device has shown safety in previous patients and aims to reduce angina episodes effectively.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic refractory angina who are not suitable for surgical or percutaneous interventions.
Not a fit: Patients with recent acute coronary syndrome, unstable angina, or those who have undergone recent PCI or CABG may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce angina episodes and improve the quality of life for patients with severe refractory angina.
How similar studies have performed: Previous studies using similar devices have shown promising safety and efficacy results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tel Aviv and 1 other locations
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- Tel Aviv Medical Center — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Shmuel Banai, Prof.
- Email: shmuelb@tasmc.health.gov.il
- Phone: 972-3-6973395
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.