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Coronary Sinus Reducer
Neovasc Reducer for Refractory Angina (COSIRA-II Trial)
N/A
Recruiting
Led By Timothy D Henry, MD
Research Sponsored by Neovasc Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 60 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization
Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 8 minutes, performed while the subject is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years
Awards & highlights
COSIRA-II Trial Summary
This trial will test the safety and effectiveness of the Neovasc Reducer system for treating patients with refractory angina pectoris who cannot be helped by current medical therapies and who also have objective evidence of reversible myocardial ischemia in the left coronary artery. The trial will also assess the safety and effectiveness of the system in selected subjects with reversible myocardial ischemia in the right coronary artery, subjects with reversible myocardial ischemia without documented obstructive coronary disease, and subjects who cannot complete an exercise tolerance test due to an above-the-ankle amputation.
Who is the study for?
This trial is for adults over 18 with persistent, severe angina (chest pain) despite using all recommended medications. They must have heart disease that can't be fixed with surgery or other procedures and show signs of reversible heart muscle stress due to poor blood flow in the left coronary artery. People with certain allergies, recent heart attacks, severe lung disease, or those who are pregnant or recently had COVID-19 cannot join.Check my eligibility
What is being tested?
The study tests the Neovasc Reducer system's safety and effectiveness in reducing chest pain from angina when standard treatments don't work. One group gets the device implanted; another undergoes a sham procedure without implantation; a third non-randomized group is observed for additional safety data.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, allergic reactions to materials in the device (stainless steel/nickel), infection risk from surgery, and possible interference with normal heart function depending on individual health conditions.
COSIRA-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least three types of heart pain medication without changing them for 60 days.
Select...
I can exercise for 2 to 8 minutes due to chest pain despite taking my heart medication.
Select...
I am older than 18 years.
Select...
I have severe heart-related chest pain that hasn't improved after 3 months despite treatment.
COSIRA-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month, 12 month, 2 years, 3 years, 4 years, and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness
Safety Events
Other outcome measures
Activity
Adverse Events
Angina Burden
+4 moreCOSIRA-II Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3 (unblinded, non-randomized): Single Arm RegistryExperimental Treatment1 Intervention
Group II: Arm 1 (treatment arm):Implantation of the Reducer deviceExperimental Treatment1 Intervention
Group III: Arm 2 (sham-control arm): Control (no device implantation)Placebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Shockwave Medical, Inc.Industry Sponsor
28 Previous Clinical Trials
7,786 Total Patients Enrolled
Neovasc Inc.Lead Sponsor
7 Previous Clinical Trials
1,035 Total Patients Enrolled
Timothy D Henry, MDPrincipal InvestigatorThe Christ Hospital Health Network
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried at least three types of heart pain medication without changing them for 60 days.I have had a test showing heart muscle stress due to narrowed arteries in the last year.I cannot take certain blood thinners for 6 months.I am in the hospital due to COVID-19.My doctor expects me to live more than a year despite my other health issues.I am not a candidate for surgery or other procedures to improve blood flow to my heart as decided by heart specialists.I can exercise for 2 to 8 minutes due to chest pain despite taking my heart medication.I am unable to give informed consent due to personal circumstances.I tested positive for COVID-19 in the last 4 weeks but have no symptoms.My main symptom of angina is shortness of breath.I had a successful heart vessel surgery or stent placement within the last 6 months.I had a failed heart artery opening procedure within the last 30 days.I have severe heart failure or was hospitalized for it in the last 3 months.I have severe COPD, need oxygen during the day, or take oral steroids.I have severe kidney problems or am on dialysis.I am older than 18 years.My heart's pumping ability is at least 30%.I have severe heart valve disease.I had COVID-19 symptoms or was hospitalized but haven't felt normal for less than 8 weeks.I am recommended to get a defibrillator or heart therapy device as per heart health guidelines.I experience chest pain due to reasons other than heart artery problems.I have severe heart-related chest pain that hasn't improved after 3 months despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 (sham-control arm): Control (no device implantation)
- Group 2: Arm 3 (unblinded, non-randomized): Single Arm Registry
- Group 3: Arm 1 (treatment arm):Implantation of the Reducer device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available for participation in this trial?
"Affirmative. Clinicaltrials.gov reveals that this clinical research is still accepting participants, having been initially posted on April 1st 2022 and recently updated on November 9th 2022. Currently there are 16 sites looking to recruit 380 patients in total."
Answered by AI
In what geographic locations is this experiment being carried out?
"This clinical experiment is being conducted at Massachusetts General Hospital in Boston, Medical City Fort Worth in Texas, and Los Robles Hospital & Medical Center located near Thousand Oaks. Additionally, there are 16 other participating sites."
Answered by AI
How many participants are presently being included in this research?
"Neovasc Inc. is responsible for the trials, which will be conducted at Massachusetts General Hospital in Boston and Medical City Fort Worth in Texas. To initiate this study, 380 qualified participants need to enrol."
Answered by AI
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