NCT05102019

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Detailed description

The COSIRA-II study is a multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial.

Conditions

• Refractory Angina

Interventions

Type	Name	Description
DEVICE	Arm 1: treatment with Shockwave Reducer	Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
OTHER	Arm 2 (control): Implantation procedure with no device implanted	No device is implanted
DEVICE	Arm 3 (unblinded, non-randomized): Single arm registry	Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms

Timeline

• Start date: 2022-01-04
• Primary completion: 2027-07-01
• Completion: 2032-01-01
• First posted: 2021-11-01
• Last updated: 2026-04-13

Locations

95 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated device study