Clinical trials: Coronary Sinus Reducer
Angina (Stable), Coronary Microvascular Disease
Coronary Sinus Reducer in Coronary Microvascular Disease
Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options.
- Trial name
- REDUCE CMD (NCT06898541)
- Testing
- Coronary sinus reducer
- Where
- 2 sites in Netherlands
- Volunteers
- 50 people
- Sponsor
- UMC Utrecht
Hypertrophic Cardiomyopathy
Coronary Sinus Reducer Objective Impact on SymptoMs, Ischaemia and miCrovascular Resistance in Non-obstructive Hypertrophic CardioMyopathy
Hypertrophic cardiomyopathy (HCM) is a common heart condition in which the heart muscle becomes abnormally thick. In non-obstructive HCM, blood flow out of the heart is not blocked, but many patients still experience chest pain…
- Trial name
- COSMIC-HCM (NCT07865364)
- Testing
- Coronary sinus reducer
- Where
- 8 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Imperial College London
Refractory Angina, Microvascular Angina
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic…
- Conditions
- Refractory Angina, Microvascular Angina, Microvascular Coronary Artery Disease, Coronary Disease
- Trial name
- REMEDY-PILOT (NCT05492110)
- Testing
- Coronary sinus reducer, Invasive coronary physiology
- Where
- United Kingdom
- Volunteers
- 54 people
- Sponsor
- Imperial College London
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.
Heart Failure Preserved Ejection Fraction
Coronary Sinus Reducer For The Management Of Symptomatic Heart Failure
The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, specifically invasive measurement of PAWP during standardized exercise.
- Trial name
- NCT07057323
- Testing
- Coronary Sinus Reducer
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Refractory Angina Pectoris
CoROnary SinuS Reducer implantatiOn for ischemiA reDuction
Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life.
- Trial name
- CrossRoad (NCT04121845)
- Testing
- Coronary Sinus Reducer device
- Where
- Slovenia
- Volunteers
- 25 people
- Sponsor
- University Medical Centre Ljubljana
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 With No Obstructive Coronary Artery Disease, ANOCA
Coronary Sinus Reducer in Patients With Angina With no Obstructive Coronary Disease
Even half of patients with angina undergoing invasive coronary angiography presents without any significant epicardial stenosis.
- Conditions
- Angina With No Obstructive Coronary Artery Disease, ANOCA, Coronary Sinus Reducer
- Trial name
- REDUCE-ANOCA (NCT07010029)
- Testing
- Coronary Sinus Reducer
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Medical University of Warsaw
Refractory Angina Pectoris
IMR Evaluation in Patients with Coronary Sinus Reducer Implantation (INROAD Study)
The INROAD is an investigator-driven, prospective, study in which patients undergoing coronary sinus reducer implantation (Reducer) for chronic refractory angina undergo evaluation of the index of microcirculatory resistance…
- Trial name
- INROAD (NCT05174572)
- Testing
- IMR
- Where
- Italy
- Volunteers
- 21 people
- Sponsor
- Consorzio Futuro in Ricerca
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.
Coronary Artery Disease, Angina (Stable)
Coronary Sinus Reducer Therapy for Persisting Angina
Refractory angina due to advanced obstructive coronary artery disease (CAD) remains a major clinical problem with limited evidence-based treatment options.
- Trial name
- REDUCE ANGINA (NCT07485985)
- Testing
- Coronary sinus reducer
- Volunteers
- 25 people
- Sponsor
- UMC Utrecht
Coronary Artery Disease, Angina Pectoris
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia
The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD).
- Trial name
- NCT06266065
- Testing
- Coronary Sinus Reducer
- Where
- Croatia
- Volunteers
- 25 people
- Sponsor
- Clinical Hospital Centre Zagreb
Refractory Angina
Use of the Neovasc Coronary Sinus Reducer System for the Treatment of Refractory Angina Pectoris in Patients With Ngina Class 3-4 Who Are Not Candidates for Revascularization
The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.
- Trial name
- Reducer (NCT01566175)
- Testing
- Neovac coronary sinus reducer
- Where
- 2 sites in Israel
- Volunteers
- 100 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Heart Failure With Preserved Ejection Fraction, Coronary Microvascular Dysfunction
A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD
To evaluate the effect of CS reducer implantation in patients with HFPEF and CMD on myocardial ischemia, measured by stress myocardial perfusion using cardiovascular magnetic resonance (CMR)
- Trial name
- NCT07093528
- Testing
- Cardiovascular Magnetic Resonance (CMR)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Mayo Clinic
Coronary Microvascular Disease, Refractory Angina
COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial.
- Trial name
- COSIMA (NCT04606459)
- Testing
- Coronary sinus reducer, Optimal medical therapy
- Where
- Germany
- Volunteers
- 144 people
- Sponsor
- Johannes Gutenberg University Mainz
Safety Issues, Efficacy, Self
Lower Silesia Sinus Reducer Registry
Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society [CCS] classes 2-4) despite maximally tolerated…
- Trial name
- LSSRR (NCT06288165)
- Testing
- Coronary Sinus Reducer Implantation
- Where
- 2 sites in Poland
- Volunteers
- 200 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Refractory Angina
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance
ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and…
- Trial name
- ORBITA-COSMIC (NCT04892537)
- Testing
- Coronary Sinus Reducer
- Where
- 5 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Imperial College London
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.