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 (Reducer)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory Angina
• Intervention / Treatment: Device: Neovac coronary sinus reducer

Detailed Description

• Interventional, Allocation: Open label, Primary Purpose: Treatment
• Diagnosis and treatment for which the device is required:Patients with advanced obstructive coronary artery disease and severe disabling refractory angina despite optimal medical therapy. No revascularization option available.
• Why this unlicensed device is chosen over a licensed device or conventional therapies for this particular patient? Patient currently treated with optimal medical therapies that include: long acting nitrates, beta blockers, and calcium channel blockers. The patient is not amendable to re-do bypass graft surgery, not amendable to percutaneous coronary intervention, as determined by recent coronary angiography.

There is no other licensed device that can effectively ameliorate refractory angina and reduce the number of angina episodes and improve quality of life.

-The current device has been used in 25 patients to date. Safety information at 6 months had been published (JACC 2007;49:1783). Extended safety and efficacy information at 3 years had been reported in March 2010 (ACC Annual Scientific conference). The device has not been associated with any procedure-related adverse events during the follow-up period.

Risks (theoretical):•Coronary sinus dissection at the time of implantation. •Coronary sinus perforation and acute cardiac tamponade requiring drainage. •Device migration and embolization. •Late coronary sinus occlusion These risk were not reported in patients who receieved the device. Benefits: •Reduce angina severity. •Improve quality of life. •Reduction in the intensity of medical therapy with decrease side effects. •Reduced incidence of hospital admissions, emergency room visits and outpatient clinic visits for refractory angina. •Improved left ventricular function, and reduced LV end diastolic pressure. These patients have poor quality of life. They are disable and unable to work or to perform basic daily activities. Cannulation of the coronary sinus presents procedural risks similar to that of pacemaker electrode insertion, a procedure which is frequently performed in Interventional cardiology. For these particular patients with poor quality of life, the offered technology can potentially make them more active, more productive, and less dependent on medication and the health system.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shmuel Banai, Prof.; Phone Number: 972-3-6973395; Email: shmuelb@tasmc.health.gov.il
• Study Contact Backup: Name: Gad Keren, Prof.; Phone Number: 972-3-6974762; Email: gadk@tasmc.health.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Medical Center
    • Contact: Shmuel Banai, Prof; Phone Number: 972-3-6973395; Email: shmuelb@tlvmc.gov.il
  • Tel Aviv, Israel, 64239
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Shmuel Banai, Prof.; Phone Number: 972-3-6973395
    • Contact: Gad Keren, Prof.; Phone Number: 972-3-6974762

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neovasc coronary sinus reducer; open label: Neovasc coronary sinus reducer	Device: Neovac coronary sinus reducer; reducer; Other Names: Reducer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Cardiovascular Society Angina Score	A decrease of two or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups	6 months

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Neovasc Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2011
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2031

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Sinus; Refractory Angina Pectoris; Neovasc Reducer; angina class 3-4
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: Neovasc Reducer