OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
NCT03716102 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2020-06-26
Summary
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Conditions
- Acute Coronary Syndrome
Interventions
- DEVICE
-
PCI with implantation with DES
PCI with implantation with DES
Sponsors & Collaborators
-
Svelte Medical Systems, Inc.
lead INDUSTRY
Principal Investigators
-
Dennis Donohoe, MD · Svelte Medical Systems
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-21
- Primary Completion
- 2020-06-15
- Completion
- 2021-07-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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