Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-02 @ 4:14 AM
Study NCT ID:
NCT04856592
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of IVUS-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein Obstruction
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Clinical Outcomes of Intravascular Ultrasound-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein Obstruction
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study device VICI stent withdrawn from market
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APAC VICI
Brief Summary:
The APAC VICI Study is a prospective, non-randomized, multicenter, single-arm study. The purpose of this study is to evaluate the clinical results of using the Boston Scientifc's Vici Venous Stent (Vici stent) to treat significant blockage in the iliofemoral veins under the guidance of intravascular ultrasound (IVUS) in ethnic Chinese patient population. The study will assess the safety and effectiveness of Vici stent implanted under the guidance of the Boston Scientific's IVUS technology (by using Opticross 35 catheter) for treating adult ethnic Chinese patients with symptomatic chronic venous obstruction in the iliofemoral veins.
During the trial, anticoagulant or antiplatlet therapy will be administered for 6 - 12 months post index procedure. Ongoing dynamic data safety monitoring will be performed throughout the trial to minimize subject risk. All enrolled subjects receiving the Vici stent treatment will be followed for 24 months post index procedure.
During the trial, anticoagulant or antiplatlet therapy will be administered for 6 - 12 months post index procedure. Ongoing dynamic data safety monitoring will be performed throughout the trial to minimize subject risk. All enrolled subjects receiving the Vici stent treatment will be followed for 24 months post index procedure.
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?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: