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

Not Applicable

Withdrawn

• Conditions: Chronic Venous Disorder; Systemic Vein Outflow of Iliofemoral Vein; Venous Outflow Obstruction
• Interventions: Device: Boston Scientific Vici® Venous Stent System; Device: Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)

• Registration Number: NCT04856592
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-23
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01
• Study Start: 2021-12-31
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Ethnic Chinese subjects of age ≥ 18 years (or meet age requirements per local law)

2. Subjects willing to provide written informed consent prior to the study and AND willing to comply with all follow-up evaluations at the specified times

3. Subjects with presence of unilateral, clinically significant, chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a > 50% reduction in target vessel lumen diameter measured by venogram and/or IVUS during procedure

4. Clinically significant venous obstruction defined as meeting at least one of the following clinical indicators:

   • Clinical severity class of CEAP classification ≥ 3
   • rVCSS Pain Score ≥ 2

5. Negative pregnancy test in female subjects of potential child-bearing

6. Intention to stent the target lesion only with the Vici Stent(s)

Key

Exclusion Criteria

Pre-Procedural EC--

1. Subjects with presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.

2. Subjects with venous obstruction that extends into the inferior vena cava

3. Subjects with contralateral disease of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof with planned treatment within 30 days after enrollment

4. Subjects with a life expectancy < 12 months

5. Female of childbearing potential who is pregnant or plans to become pregnant during the duration of the clinical study (Note: subjects who plan to become pregnant after 12-month follow-up visit may be included in the trial at the discretion of treating physician)

6. A. Subjects with uncontrolled or active coagulopathy OR

   B. Subjects with known uncorrectable bleeding diathesis with the following definitions:

   • Uncorrected INR ≥ 2.0 or aPTT ≥ 1.5X normal local lab value
   • Platelet count < 80,000

7. Subjects with uncorrected hemoglobin of ≤ 9 g/dL

8. Subjects with an estimated glomerular filtration rate (eGFR) < 30 mL/min. In patients with diabetes mellitus, eGFR < 45 mL/min.

9. Subjects have known hypersensitivity to nickel or titanium

10. Subjects have contrast agent allergy that cannot be managed adequately with pre-medication

11. Subjects will have intended concurrent thrombolysis or thrombectomy procedure OR intended or planned (within 30 days) adjuvant procedure such as creation of temporary AV fistula, placement of IVC filter, endovenectomy or saphenous vein ablation

12. Subjects currently participating in another drug or device clinical trial (participation in observational studies is acceptable)

13. Subjects judged to be a poor candidate by the primary investigator

14. Subjects who have had any prior surgical or endovascular intervention of the target vessel

Intra-Procedural:

1. Subjects in whom the lesions cannot be traversed with a guide wire
2. Subjects where the obstruction extends into the inferior vena cava or below the level of the lesser trochanter
3. Subjects whose vein diameters are not within limits stated in the Instructions for Use of study device as determined by venogram and/or IVUS
4. Subjects who do not meet the venogram or IVUS binary stenosis by the definition above (IC3), as determined by the treating physician
5. Subjects who are judged by treating physician to have a lesion that prevents completed inflation of a balloon dilation catheter or proper placement of the stent or the stent delivery system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VICI Stent	Boston Scientific Vici® Venous Stent System	-
VICI Stent	Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)	-

Primary Outcome Measures

Name	Time	Method
The primary patency rate at 12 months post index procedure	12 month	Defined as freedom from occlusion by thrombosis AND freedom from surgical or endovascular intervention on target vessel which are found to have restenosis or stent occlusion to maintain patency AND freedom from in-stent stenosis more than 50% by DUS.
Major Adverse Events within 30 days post index procedure	30 days	The composite endpoint of below major adverse events (MAE) adjudicated by the Clinical Events Committee (CEC) within 30 days post index procedure: * Device or procedure-related death; * Device or procedure-related bleeding at the target vessel and/or the target lesion or at the access site requiring surgical or endovascular intervention or blood transfusion ≥ 2 units; * Device or procedure-related arterial or venous injury occurring in the target vessel segment and/or target lesion or at the access site requiring surgical or endovascular intervention; * Device or procedure related acute DVT outside of the target vein segment; * Clinically significant pulmonary embolism defined as being symptomatic with chest pain, hemoptysis, dyspnea, hypoxia etc... AND be documented on CT; * Stent embolization; * Stent thrombosis