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Clinical Outcomes of IVUS-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein Obstruction

NCT04856592 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

  • Chronic Venous Disorder
  • Venous Outflow Obstruction
  • Systemic Vein Outflow of Iliofemoral Vein

Interventions

DEVICE

Boston Scientific Vici® Venous Stent System

The Vici Venous Stent System comprises two components: the implantable endoprosthesis and its stent delivery system, a 9F over-the-wire system available in a 100cm length and compatible with 0.035in (0.89mm) guidewires

DEVICE

Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)

The Opticross 35 catheter is designed for use with a guidewire measuring ≤0.035 in (0.89 mm) in diameter and an introducer sheath of 8F (2.67 mm) or larger. The working length of OC35 catheter is 105 cm.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856592 on ClinicalTrials.gov