Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-12 @ 12:55 AM
Study NCT ID:
NCT02305602
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2014-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of VentriGel in Post-MI Patients
Sponsor:
Ventrix, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Open-label Study of the Effects of Percutaneous Administration of an Extracellular Matrix Hydrogel, VentriGel, Following Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2019-10
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:
This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the past 3 years and have evidence of left ventricular remodeling.
Detailed Description:
Evaluate the safety and feasibility of VentriGel delivered trans-endocardially to subjects with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints will look at efficacy variables of ESV, EDV, EF, scar mass.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: