Clinical trials: Coronary Sinus Reducer
Angina Pectoris, Myocardial Ischemia
Self Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
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…
- Conditions
- Angina Pectoris, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases
- Trial name
- SERRA-I US (NCT07449325)
- Testing
- A-FLUX Reducer System
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- VahatiCor, Inc.
Refractory Angina
Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA
The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.
- Trial name
- COSIRA (NCT01205893)
- Testing
- Neovasc Reducer, Control
- Where
- 11 sites in Belgium, Canada and 4 more
- Volunteers
- 104 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD) (SERRA-I Study)
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…
- Trial name
- NCT06991322
- Testing
- A-FLUX Reducer System
- Where
- 3 sites in Netherlands, Poland and 1 more
- Volunteers
- 30 people
- Sponsor
- VahatiCor, Inc.
Angina Pectoris, Angina Pectoris, Stable
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
- Conditions
- Angina Pectoris, Angina Pectoris, Stable, Chronic Stable Angina
- Trial name
- NCT02710435
- Testing
- Reducer System
- Where
- 25 sites in Austria, Belgium and 7 more
- Volunteers
- 400 people
- Sponsor
- Shockwave Medical, Inc.
Refractory Angina
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
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…
- Trial name
- COSIRA-II (NCT05102019)
- Testing
- Arm 1: treatment with Shockwave Reducer, Arm 2 (control): Implantation procedure with no device implanted, Arm 3 (unblinded, non-randomized): Single arm registry
- Where
- 97 sites in United States, Canada and 1 more
- Volunteers
- 380 people
- Sponsor
- Shockwave Medical, Inc.