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Chronic Venous DisorderAPAC VICINCT04856592

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

A study testing Boston Scientific Vici® Venous Stent System and Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter) in people with Chronic Venous Disorder and Venous Outflow Obstruction, run by Boston Scientific Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Boston Scientific Vici® Venous Stent System and Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Dec 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ethnic Chinese subjects of age ≥ 18 years (or meet age requirements per local law)
  • 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
  • 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
  • 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
  • Negative pregnancy test in female subjects of potential child-bearing
  • Intention to stent the target lesion only with the Vici Stent(s)

Who cannot join

  • Pre-Procedural EC--
  • Subjects with presence or history of clinically significant pulmonary emboli within 6 months prior to enrollment.
  • Subjects with venous obstruction that extends into the inferior vena cava
  • 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
  • Subjects with a life expectancy < 12 months
  • 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)
Show all 24Show fewer
  • A. Subjects with uncontrolled or active coagulopathy OR
  • 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
  • Subjects with uncorrected hemoglobin of ≤ 9 g/dL
  • Subjects with an estimated glomerular filtration rate (eGFR) < 30 mL/min. In patients with diabetes mellitus, eGFR < 45 mL/min.
  • Subjects have known hypersensitivity to nickel or titanium
  • Subjects have contrast agent allergy that cannot be managed adequately with pre-medication
  • 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
  • Subjects currently participating in another drug or device clinical trial (participation in observational studies is acceptable)
  • Subjects judged to be a poor candidate by the primary investigator
  • Subjects who have had any prior surgical or endovascular intervention of the target vessel
  • Intra-Procedural:
  • Subjects in whom the lesions cannot be traversed with a guide wire
  • Subjects where the obstruction extends into the inferior vena cava or below the level of the lesser trochanter
  • Subjects whose vein diameters are not within limits stated in the Instructions for Use of study device as determined by venogram and/or IVUS
  • Subjects who do not meet the venogram or IVUS binary stenosis by the definition above (IC3), as determined by the treating physician
  • 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

About this study

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

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.

Being tested
Boston Scientific Vici® Venous Stent System, Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boston Scientific Vici® Venous Stent SystemDevice

    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

  • Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)Device

    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.

Study groups in NCT04856592
Study groupRoleWhat they receive
VICI StentExperimentalNot described
Receives: Device: Boston Scientific Vici® Venous Stent System; Device: Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary patency rate at 12 months post index procedure

    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.

    Measured: 12 month

  2. Major Adverse Events within 30 days post index procedure

    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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start31 Dec 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: The study device VICI stent withdrawn from market

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04856592
Sponsor's protocol ID
S2484
Acronym
APAC VICI
Status last verified
Oct 2021
First submitted
12 Apr 2021
Last updated
1 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Boston Scientific Vici® Venous Stent System and Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter) in people with Chronic Venous Disorder and Venous Outflow Obstruction, run by Boston Scientific Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary patency rate at 12 months post index procedure (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04856592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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