REDUCER-I: An Observational Study of the Neovasc Reducer™ System
NCT: NCT02710435 ·
Status: ACTIVE NOT RECRUITING ·
Phase: N/A
· Sponsor: Shockwave Medical, Inc.
· Started: 2016-03
· Est. Completion: 2028-12
Official Summary
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 400 participants
Interventions
- DEVICE: Reducer System — An aid in the management of chronic refractory angina pectoris
Primary Outcomes
- Reduction in Canadian Cardiovascular Society (CCS) Grade (6 Months)
- Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s (30 days post implant)
- Occurrence of Major Adverse Cardiac Events (MACE) (30 days post implant)
Secondary Outcomes
- Reduction in Canadian Cardiovascular Society (CCS) Grade (12 months and annually through 5 years)
- Occurrence of Major Adverse Cardiac Events (MACE) (6 months, 12 months, and annually through 5 years)
Trial Locations
- University of Graz, Graz, Austria
- ZNA Middelheim Hospital, Antwerp, Belgium
- Zienkenhuis Oost-Limburg, Genk, Belgium
- University Hospital of Brest, Brest, France
- Institut Coeur Poumon, Lille, France
- Kerckhoff Klinik, Bad Nauheim, Germany
- Dresden University, Dresden, Germany
- Contilia Heart and Vascular Centre, Elisabeth Krankenhaus Essen, Klinik fϋr Kardiologie und Angiologie, Essen, Germany
- University Heart Center Freiburg - Bad Krozingen, Freiburg im Breisgau, Germany
- University Giessen, Giessen, Germany
- ...and 10 more locations
More Angina Pectoris Trials
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.