- Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT05102019.
- Device Being Tested: The Shockwave Reducer, a coronary sinus reducer device designed to increase coronary perfusion pressure and improve myocardial blood flow in patients with refractory angina despite maximum medical therapy.
- Patient Eligibility Overview: Adults with refractory angina pectoris on maximally tolerated guideline-directed medical therapy who have objective evidence of reversible myocardial ischemia in the left coronary artery distribution and are unsuitable for or have failed revascularisation.
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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…
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- Subject is older than 18 years of age 2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea 3. Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.