Arm 2 (control): Implantation procedure with no device implanted
Arm 3 (unblinded, non-randomized): Single arm registry
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
January 4, 2022
Trial end date
January 1, 2032
CT.gov ID
#NCT05102019
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
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.
Primary outcome measures
Effectiveness
Safety Events
Secondary outcome measures
Canadian Cardiovascular Society (CCS) Angina Score
Canadian Cardiovascular Society (CCS) Angina Score