Implanting a device to treat severe angina in patients who can't undergo surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Advanced invasive diagnosis for post-PCI angina in patients referred for coronary angiography

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• Lesion-specific angina thresholds measured during invasive coronary testing

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.