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

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.

NCT Number	NCT05102019
Lead Sponsor	Shockwave Medical, Inc.
Conditions	Refractory Angina
Enrollment	380 participants
Start Date	2022-01-04
Primary Completion	2027-07 (estimated)
Study Completion	2032-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-12