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New treatment option for Refractory Angina
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
ClinicalTrials.gov ID: NCT01566175
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \>18 years old
- Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal...
- 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 likely can't join 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
See the full eligibility 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
- 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\>...
The study team makes the final eligibility decision.
Where it's taking place
- Tel Aviv, Israel
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.