Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03190473
Status:
TERMINATED
Last Update Posted:
2023-03-23
First Post:
2017-06-14
Brief Title:
OPTIMIZE IDE for the Treatment of ACS
Sponsor:
Svelte Medical Systems Inc
Organization:
Svelte Medical Systems Inc
Study Overview
Official Title:
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company financial insolvency not due to safety or efficacy concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMIZE
Brief Summary:
Indication for use The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 225 mm - 400 mm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None