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

Conditions

• Refractory Angina

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 4, 2022

Status verified

Apr 2026

Primary completion

Jul 31, 2027

Completion

Jan 31, 2032

Study Design

Enrollment

380 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 (treatment arm):Implantation of the Reducer device
• Sham Comparator: Arm 2 (sham-control arm): Control (no device implantation)
• Other: Arm 3 (unblinded, non-randomized): Single Arm Registry

Primary Outcome Measure

Co-Primary Effectiveness Endpoints [ Time Frame: 6 months ]

Central Contacts

• COSIRA-II Study Team
  Fax: 1-888-887-8097
  [email protected]

Locations (70)

Find similar trials in Phoenix, AZ

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