Trials / Withdrawn
WithdrawnNCT04856592
Clinical Outcomes of IVUS-guided Stenting Using the Boston Scientific Vici® Venous Stent System in Treating Patients With Chronic Non-malignant Iliofemoral Vein Obstruction
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- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-31
- Primary completion
- 2022-12-31
- Completion
- 2023-12-31
- First posted
- 2021-04-23
- Last updated
- 2021-11-01
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04856592. Inclusion in this directory is not an endorsement.