Trials / Active Not Recruiting
Active Not RecruitingNCT02710435
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
Detailed description
This study is a multicenter, multi-country three-arm prospective and retrospective investigation in up to 400 subjects conducted at a maximum of 40 investigational centers. Arm 1 will include eligible prospective subjects. Arm 2 will include subjects who were previously enrolled and treated with the Reducer during the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study. Arm 3 will include subjects who received a Reducer under CE Mark (unrelated to the COSIRA study).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Reducer System | An aid in the management of chronic refractory angina pectoris |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2023-11-01
- Completion
- 2028-12-01
- First posted
- 2016-03-16
- Last updated
- 2026-04-03
Locations
25 sites across 9 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT02710435. Inclusion in this directory is not an endorsement.