Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)
NCT04562805 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400
Last updated 2024-10-16
Summary
The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx).
Conditions
- Coronary Artery Disease
- Ischemic Heart Disease
Interventions
- DEVICE
-
DynamX Bioadaptor
DynamX Bioadaptor Treatment
- DEVICE
-
Resolute Onyx
Resolute Onyx Treatment
Sponsors & Collaborators
-
Uppsala University
collaborator OTHER -
Elixir Medical Corporation
lead INDUSTRY
Principal Investigators
-
David Erlinge, MD, PhD · Skane University Hospital, Lund
-
Stefan James, MD, PhD · Uppsala University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-30
- Primary Completion
- 2024-09-05
- Completion
- 2028-07-31
- FDA Device
- Yes
Countries
- Sweden
Study Locations
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