NCT01566175Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 2 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 27 Mar 2012
- Start date
- Aug 2011
- Primary completion date
- Dec 2030
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT01566175
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Aug 2011 to the primary completion date, Dec 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Recent (within three months) acute coronary syndrome
- 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
- Known allergy to stainless steel or nickel
Other
- Recent (within six months) PCI or CABG
- Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
- Patient having undergone tricuspid valve replacement or repair
- 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
Who the study is looking for
- \>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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tel Aviv Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.