Trials / Not Yet Recruiting
Not Yet RecruitingNCT07449325
Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
- Status
- Not Yet 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
- Angina Pectoris
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Microvascular Angina
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
- 2026-04-01
- Primary completion
- 2026-11-01
- Completion
- 2027-12-01
- First posted
- 2026-03-04
- Last updated
- 2026-03-04
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07449325. Inclusion in this directory is not an endorsement.