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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborator:
Neovasc Inc.
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01566175
First received: March 27, 2012
Last updated: August 10, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Refractory Angina
Device: Neovac coronary sinus reducer

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
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)
Arms Assigned Interventions
Experimental: Neovasc coronary sinus reducer
open label: Neovasc coronary sinus reducer
Device: Neovac coronary sinus reducer
reducer
Other Name: Reducer

Detailed Description:
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  • 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> 12mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566175

Contacts
Contact: Shmuel Banai, Prof. 972-3-6973395 shmuelb@tasmc.health.gov.il
Contact: Gad Keren, Prof. 972-3-6974762 gadk@tasmc.health.gov.il

Locations
Israel
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel
Contact: Shmuel Banai, Prof    972-3-6973395    shmuelb@tlvmc.gov.il   
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      
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Neovasc Inc.
  More Information

No publications provided

Responsible Party: michal roll, Prof. Gad Keren, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01566175     History of Changes
Other Study ID Numbers: Neovasc Reducer
Study First Received: March 27, 2012
Last Updated: August 10, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Tel-Aviv Sourasky Medical Center:
Neovasc Reducer
Coronary Sinus
Refractory Angina Pectoris
angina class 3-4

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014