RecruitingNAINTERVENTIONAL

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

This research is investigating a new treatment for severe chest pain, known as refractory angina. This type of angina means that standard medicines and procedures haven't worked to ease the pain. The study focuses on a device called the 'Shockwave Reducer', which is designed to improve blood flow to the heart in people who can't have other heart procedures like bypass surgery or stents. The main goal is to find out if this device is safe and effective in reducing chest pain and improving quality of life for these patients. Some patients will receive the device, while others will have a 'sham' procedure (not actually receiving the device) to fairly compare its effects. There's also a smaller part of the study for different groups of patients.

At a glance

Status

Recruiting

Phase

Sponsor

Shockwave Medical, Inc.

Enrolment target

380

Start

04 Jan 2022

Estimated completion

01 Jan 2032

Refractory Angina

What is this study about?

This study is about a problem called "refractory angina." This is a type of severe chest pain that happens when your heart doesn't get enough blood, even after you've tried many different medicines and other treatments. For some people, standard heart procedures like bypass surgery or having stents put in aren't possible or safe. This can leave them with ongoing, painful symptoms that affect their daily life.

The research is looking at a new device called the 'Shockwave Reducer'. This device is designed to be placed in a blood vessel around the heart to help improve blood flow. The main aim is to see if this Reducer can safely and effectively reduce the chest pain and make people feel better when other treatments haven't worked.

The study involves comparing patients who receive the Reducer with a control group who undergo a similar procedure but don't actually have the device implanted (this is called a 'sham' procedure). This helps researchers understand if any improvements are truly due to the device. There's also a smaller part of the study to see how the device works in other groups of patients, including those with slightly different heart conditions.

Key takeaways

This study is for severe, hard-to-treat chest pain (angina).
It tests a new device called the 'Shockwave Reducer'.
It's for people who cannot have bypass surgery or stents.
Participation might involve a 'sham' procedure (no device).
The primary goal is to assess safety and pain relief.
You'll continue your usual heart medications.

Who may be eligible?

To join this study, you need to be over 18 years old and have severe, ongoing chest pain (angina) that has lasted for at least three months. This pain must be so bad that it falls into what doctors call CCS Grade III or IV, even though you’ve been taking the strongest possible heart medications directed by your doctor.

You also need to have tried most of the standard anti-angina medications, and your medical team must have decided that you can't have other heart procedures like bypass surgery or stents, or that these procedures would be too risky for you. Importantly, medical tests must also show that parts of your heart muscle aren't getting enough blood during stress or exercise.

The study has some very specific requirements, and a team of heart specialists will review your case to make sure you meet all the criteria before you can be considered for enrolment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Do you have severe chest pain that has lasted at least 3 months despite medications?
Has your doctor said you cannot have other heart procedures like bypass surgery or stents?
Have you tried many different heart medications for your chest pain?
Have tests shown parts of your heart aren't getting enough blood during stress?

Answer every question to see your result.

What does participation involve?

If you join this study, you might receive the Shockwave Reducer device or undergo a 'sham' procedure, which is similar but doesn't involve implanting the device. This is decided by chance, like flipping a coin. You'll have regular hospital visits for check-ups and tests, including heart scans and assessments of your chest pain symptoms. The study doesn't involve new medications, but you will need to continue your current heart medicines, and these doses are not expected to change for at least a year after you join. The total duration of follow-up for this study will be decided by the researchers, but will involve a series of visits over time to track your progress and safety.

Potential risks and benefits

Taking part in this study could potentially help reduce your severe chest pain if the Shockwave Reducer works as hoped. However, as with any medical procedure, there are potential risks, including those associated with the implantation process itself, such as bleeding or infection. You will be closely monitored, and your doctors will explain all potential risks in detail. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic
Verified postcode
Phoenix, United States· Recruiting
HonorHealth Research Institute
Verified postcode
Scottsdale, United States· Recruiting
University of Arizona Sarver Heart Center
Verified postcode
Tucson, United States· Recruiting
Long Beach VA Medical Center
Verified postcode
Long Beach, United States· Withdrawn
Cedars-Sinai
Verified postcode
Los Angeles, United States· Recruiting
UCSD
Verified postcode
San Diego, United States· Recruiting
Kaiser Permanente San Francisco
Verified postcode
San Francisco, United States· Recruiting
UCSF
Verified postcode
San Francisco, United States· Recruiting
Los Robles Hospital and Medical Center
Verified postcode
Thousand Oaks, United States· Recruiting
South Denver Cardiology Associates
Verified postcode
Littleton, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Recruiting
MedStar Cardiovascular Research Network
Verified postcode
Washington D.C., United States· Recruiting

Common questions

What is 'refractory angina'?

It's severe ongoing chest pain from heart disease that hasn't improved with standard medications or procedures.

What is the 'Shockwave Reducer'?

It's a small device designed to improve blood flow to the heart muscle, potentially easing chest pain, for people who can't have other treatments.

Will I definitely get the device if I join?

No, you might be chosen by chance to receive the device or to have a 'sham' procedure (without the device), so researchers can fairly compare the results.

How long does the study last?

The study involves regular check-ups and assessments, but the exact total duration of your participation will be explained by the study team.

Will my regular heart medicines change during the study?

No, you will continue your current heart medicines, and they are expected to stay stable for at least 12 months after you join.

How to find out more

COSIRA-II Study Team

connect.cosira2@shockwavemedical.com Fax: 1-888-887-8097 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.