NCT06991322

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: VahatiCor, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Microvascular Dysfunction
• Coronary Microvascular Disease

Interventions

Type	Name	Description
DEVICE	A-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.

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2025-05-27
• Last updated: 2025-12-23

Locations

2 sites across 2 countries: Netherlands, Poland

Regulatory

• FDA-regulated device study