What side effects are associated with this type of intervention?

Common treatments for angina, such as pharmacologic therapies (e.g., beta-blockers, calcium channel blockers, nitrates), revascularization procedures (e.g., percutaneous coronary intervention, coronary artery bypass grafting), and mechanical devices like the Neovasc Reducer System, can have various side effects. Pharmacologic therapies may cause hypotension, bradycardia, dizziness, and gastrointestinal disturbances. Revascularization procedures carry risks of bleeding, infection, and restenosis. The Neovasc Reducer System, which creates a controlled narrowing in the coronary sinus to improve myocardial perfusion, may lead to procedural complications such as pain at the implantation site, bleeding, and, in rare cases, device migration or thrombosis.

What prior FDA approvals exist?

Traditional FDA-approved treatments for angina include medications like nitrates, beta-blockers, and calcium channel blockers, which reduce myocardial oxygen demand. Revascularization procedures such as PCI and CABG are also standard. The Neovasc Reducer System, which creates a controlled narrowing in the coronary sinus to improve myocardial perfusion, represents a novel approach in interventional cardiology. While specific FDA approvals for similar devices are not detailed, this method aligns with broader strategies to enhance myocardial perfusion.

What other types of research exist?

Promising novel alternatives to the Neovasc Reducer System for angina patients include: 1) Enhanced External Counterpulsation (EECP) - a non-invasive treatment that improves blood flow to the heart. 2) Coronary Sinus Occlusion Devices - similar to the Reducer but with different mechanisms or materials. 3) Gene Therapy - targeting angiogenesis to promote new blood vessel growth in the heart. 4) Stem Cell Therapy - using stem cells to repair and regenerate heart tissue. 5) New pharmacological agents - such as ranolazine or ivabradine, which improve myocardial efficiency and reduce angina symptoms.

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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

Must not have

Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant

Subject is currently hospitalized for definite or suspected COVID-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years

Summary

This trial tests the Reducer system, a device to improve heart blood flow, in patients with severe chest pain not relieved by standard treatments and unsuitable for surgery. The device works by redirecting blood flow to needy heart areas by narrowing a vein. The Reducer system has been shown to improve chest pain symptoms and heart function in patients with persistent chest pain.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried at least three types of heart pain medication without changing them for 60 days.

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I can exercise for 2 to 8 minutes due to chest pain despite taking my heart medication.

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I am older than 18 years.

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I have severe heart-related chest pain that hasn't improved after 3 months despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take certain blood thinners for 6 months.

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I am in the hospital due to COVID-19.

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My doctor expects me to live more than a year despite my other health issues.

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I tested positive for COVID-19 in the last 4 weeks but have no symptoms.

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I had a successful heart vessel surgery or stent placement within the last 6 months.

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I had a failed heart artery opening procedure within the last 30 days.

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I have severe heart failure or was hospitalized for it in the last 3 months.

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I have severe COPD, need oxygen during the day, or take oral steroids.

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I have severe kidney problems or am on dialysis.

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I have severe heart valve disease.

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I am recommended to get a defibrillator or heart therapy device as per heart health guidelines.

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I experience chest pain due to reasons other than heart artery problems.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness

Safety Events

Other study objectives

Activity

Adverse Events

Angina Burden

+4 more

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for angina include nitrates, beta-blockers, calcium channel blockers, and the Neovasc Reducer System. Nitrates work by dilating blood vessels, reducing the heart's workload and improving blood flow to the myocardium. Beta-blockers decrease heart rate and contractility, reducing oxygen demand. Calcium channel blockers relax blood vessels and decrease heart rate, also lowering oxygen demand. The Neovasc Reducer System creates a controlled narrowing in the coronary sinus, which increases pressure and redirects blood flow to ischemic areas of the heart, improving myocardial perfusion. These mechanisms are crucial for angina patients as they help alleviate chest pain by improving oxygen delivery to the heart muscle and reducing its workload.