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COSIRA-II Study for Refractory Angina

This study is testing a device called the Shockwave Reducer for people with refractory angina. Refractory angina is chest pain that doesn't go away even with the best available treatments. The study wants to see if the Shockwave Reducer can safely and effectively reduce your angina symptoms. You might be able to join if you are over 18, have severe angina (CCS Grade III or IV) for at least 90 days, and your doctors have determined that other treatments like bypass surgery or stents are not suitable for you. The study is currently enrolling about 380 participants, and researchers will look at how well the device works and its safety after 6 months.

Study design
This is a randomized, double-blinded, sham-controlled study with 380 participants. There is also a non-randomized group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 6 months after treatment to assess effectiveness and safety.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05102019

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

Recruiting
NAAges 18+InterventionalTreatment
Shockwave Medical, Inc.
~380 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Arm 1: treatment with Shockwave ReducerArm 2 (control): Implantation procedure with no device implantedArm 3 (unblinded, non-randomized): Single arm registry

At a glance

Recruiting sites
91 of 96 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Co-Primary Effectiveness Endpoints
Measured over 6 months
+1 more outcome measured

Conditions

Refractory Angina

Explore related trials

Refractory angina

Where it's being run

96 sites across 31 states
United Kingdom20
Texas8
California7
Florida7
Michigan5
New York5
Georgia4
Arizona3

Study leadership

  • Timothy D Henry, MD · PRINCIPAL_INVESTIGATOR · The Christ Hospital Health Network
  • Gregg W Stone, MD · PRINCIPAL_INVESTIGATOR · Mt. Sinai Heart Health

Who to contact

COSIRA-II Study Team
[email protected]
Fax: 1-888-887-8097
Email the study team

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What this trial measures

  • Co-Primary Effectiveness Endpoints6 months

    Change in total exercise duration in a modified Bruce treadmill exercise tolerance testing evaluation in the Treatment arm compared to Sham-control arm. Change in SAQ clinical summary score assessed at 6 months post procedure compared to baseline in the Treatment arm compared to the Sham-control arm.

  • Primary Safety Endpoints6 months

    The rate of occurrence of a composite of death, myocardial infarction (MI), pericardial effusion requiring surgical or percutaneous intervention, device embolization, or BARC 3 or 5 bleeding evaluation in the Treatment arm compared to the Sham-control arm.