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

NCT01566175 | Recruiting

• 1 other identifier: Neovasc Reducer
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Refractory Angina

Keywords

Neovasc Reducer; Coronary Sinus; Refractory Angina Pectoris; angina class 3-4

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Neovasc coronary sinus reducer

EXPERIMENTAL

open label: Neovasc coronary sinus reducer

Device: Neovac coronary sinus reducer

Interventions

Neovac coronary sinus reducer DEVICE

reducer

Also known as: Reducer

Neovasc coronary sinus reducer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Shockwave Medical, Inc.: collaborator

Study Sites (2)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shmuel Banai, Prof.

CONTACT

972-3-6973395; shmuelb@tasmc.health.gov.il

Gad Keren, Prof.

CONTACT

972-3-6974762; gadk@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Gad Keren

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: August 30, 2011
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 2, 2022

Record last verified: 2022-02

Locations

IL (2)