Chronic Venous Disorder, Systemic Vein Outflow of Iliofemoral Vein, Venous Outflow Obstruction
Conditions
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.
Interventions
DEVICEBoston 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
DEVICEBoston 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
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed