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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \>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
Locations
Other Locations
Israel
Tel Aviv Medical Center
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Shmuel Banai, Prof.
shmuelb@tasmc.health.gov.il
972-3-6973395
Backup
Gad Keren, Prof.
gadk@tasmc.health.gov.il
972-3-6974762
Time Frame
Start Date: 2011-08-30
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Neovasc coronary sinus reducer
open label: Neovasc coronary sinus reducer
Related Therapeutic Areas
Sponsors
Leads: Tel-Aviv Sourasky Medical Center
Collaborators: Shockwave Medical, Inc.