Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-06 @ 9:58 AM
Study NCT ID:
NCT03716102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-06-26
First Post:
2018-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Sponsor:
Svelte Medical Systems, Inc.
Organization:
Study Overview
Official Title:
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Detailed Description:
This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: