Actively Recruiting
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
Led by Tel-Aviv Sourasky Medical Center · Updated on 2022-02-02
100
Participants Needed
2
Research Sites
1061 weeks
Total Duration
On this page
Sponsors
T
Tel-Aviv Sourasky Medical Center
Lead Sponsor
S
Shockwave Medical, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Diagnosed with symptomatic coronary artery disease and chronic refractory angina classified as Canadian Cardiovascular Society grade III or IV despite optimal medical therapy for at least 30 days
- Not eligible for surgical or percutaneous coronary intervention, confirmed by two independent internal medicine professors
- Evidence of reversible ischemia in the left ventricular wall shown by Dobutamine Stress Echocardiography or Thallium Scan
You will not qualify if you...
- Acute coronary syndrome within the last three months
- Percutaneous coronary intervention or coronary artery bypass graft surgery within the last six months
- Unstable angina or recent onset angina with ECG changes within 30 days before screening
- Decompensated congestive heart failure or hospitalization for heart failure within the last three months
- Life-threatening or pacemaker/defibrillator-requiring rhythm disorders
- Severe chronic obstructive pulmonary disease with forced expiratory volume less than 55% predicted
- Severe valvular heart disease
- Presence of pacemaker or defibrillator leads in the right atrium, right ventricle, or coronary sinus
- History of tricuspid valve replacement or repair
- Known allergy to stainless steel or nickel
- Abnormal coronary sinus anatomy or diameter greater than 12 mm at implantation site as shown by angiogram
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
2
Tel Aviv Medical Center
Tel Aviv, Israel
Actively Recruiting
Research Team
S
Shmuel Banai, Prof.
CONTACT
G
Gad Keren, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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