Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)

Study acronym: SERRA-I US
StatusSuspended
PhaseNot applicable
Started

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Record History

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  1. Recruitment suspended Sponsor's reason: Study suspended to implement a protocol change
    • Eligibility criteria expanded, about 28 words
    • Site details revised at 3 of 3 sites
  2. Study sites: 2 to 3
    • Start date changed from estimate of Apr 2026 to Apr 7, 2026
    v4
  3. Recruitment opened
    • Study sites: 1 to 2
    v3
  4. Study Status, Contacts/Locationsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
VahatiCor's Coronary Sinus Reducer (A-FLUX) has been designed to improve angina or angina-like symptoms in patients with CMD. SERRA-I is an early feasibility study that evaluates the safety and clinical performance of the A-FLUX Reducer in this population.
Trial Details
NCT Number NCT07449325
Lead Sponsor VahatiCor, Inc.
Conditions
(from sponsor)		 Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Vascular Diseases, Microvascular Angina
Related terms Angina Pectoris, Cardiovascular Diseases, Heart Diseases, Microvascular Angina, Myocardial Ischemia, Vascular Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov