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
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Canadian Cardiovascular Society Angina Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Neovasc coronary sinus reducer
open label: Neovasc coronary sinus reducer
Device: Neovac coronary sinus reducer
Other Name: Reducer
- Interventional, Allocation: Open label, Primary Purpose: Treatment
- Diagnosis and treatment for which the device is required:Patients with advanced obstructive coronary artery disease and severe disabling refractory angina despite optimal medical therapy. No revascularization option available.
- Why this unlicensed device is chosen over a licensed device or conventional therapies for this particular patient? Patient currently treated with optimal medical therapies that include: long acting nitrates, beta blockers, and calcium channel blockers. The patient is not amendable to re-do bypass graft surgery, not amendable to percutaneous coronary intervention, as determined by recent coronary angiography.
There is no other licensed device that can effectively ameliorate refractory angina and reduce the number of angina episodes and improve quality of life.
-The current device has been used in 25 patients to date. Safety information at 6 months had been published (JACC 2007;49:1783). Extended safety and efficacy information at 3 years had been reported in March 2010 (ACC Annual Scientific conference). The device has not been associated with any procedure-related adverse events during the follow-up period.
Risks (theoretical):•Coronary sinus dissection at the time of implantation. •Coronary sinus perforation and acute cardiac tamponade requiring drainage. •Device migration and embolization. •Late coronary sinus occlusion These risk were not reported in patients who receieved the device. Benefits: •Reduce angina severity. •Improve quality of life. •Reduction in the intensity of medical therapy with decrease side effects. •Reduced incidence of hospital admissions, emergency room visits and outpatient clinic visits for refractory angina. •Improved left ventricular function, and reduced LV end diastolic pressure. These patients have poor quality of life. They are disable and unable to work or to perform basic daily activities. Cannulation of the coronary sinus presents procedural risks similar to that of pacemaker electrode insertion, a procedure which is frequently performed in Interventional cardiology. For these particular patients with poor quality of life, the offered technology can potentially make them more active, more productive, and less dependent on medication and the health system.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566175
|Contact: Shmuel Banai, Prof.||firstname.lastname@example.org|
|Contact: Gad Keren, Prof.||email@example.com|
|Tel Aviv Sourasky Medical Center||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Shmuel Banai, Prof. 972-3-6973395|
|Contact: Gad Keren, Prof. 972-3-6974762|