Trials / Completed
CompletedNCT04523168
Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Amir Lerman · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patients with coronary microvascular dysfunction.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | The Neovasc Reducer™ System | A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it. |
Timeline
- Start date
- 2021-06-28
- Primary completion
- 2023-07-28
- Completion
- 2023-07-28
- First posted
- 2020-08-21
- Last updated
- 2024-08-20
- Results posted
- 2024-08-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04523168. Inclusion in this directory is not an endorsement.