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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (95)