Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-03 @ 1:07 AM
Study NCT ID:
NCT02890160
Status:
UNKNOWN
Last Update Posted:
2023-10-25
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II
Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-II
Status:
UNKNOWN
Status Verified Date:
2023-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
FUTURE-II
Brief Summary:
The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial.
Detailed Description:
This study is a prospective, multicenter, single-blind, randomized controlled trial in patients with coronary artery disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. The goal is to evaluate the safety and effectiveness of Firesorb to support the approval of the Chinese Food and Drug Administration (CFDA) for this product. The Abbott's XIENCE Everolimus-eluting Coronary Stent System is selected as the control device. 430 subjects will be recruited. All subjects will be 1:1 randomly assigned to experimental group and control group. All subjects will undergo clinical follow-up at 1-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-index procedure. All subjects will undergo angiographic follow-up at 1-year post-index procedure; of which 3-5 centers will be specified as a subgroup to complete OCT follow-up (n=80, 40 each in test and control group).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: