RecruitingNot ApplicableNCT06991322

Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)


Sponsor

VahatiCor, Inc.

Enrollment

30 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called A-FLUX Reducer System for people with coronary microvascular dysfunction and coronary microvascular disease. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEA-FLUX Reducer System

The VahatiCor A-FLUX Reducer System is an implantable, self-expanding dense-cell nitinol coronary sinus flow restrictor device pre-loaded into the A-FLUX Delivery Catheter.


Locations(3)

University Medical Center Utrecht

Utrecht, Netherlands

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu

Warsaw, Poland

Hospital Clínic Barcelona

Barcelona, Spain

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NCT06991322


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