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Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System

Primary Purpose

Pulmonary Embolism, Deep Vein Thrombosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vena cava filter implantation (LUMIFI with Crux VCF System)
Sponsored by
Volcano Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring vena cava filter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is >18 years of age.
  2. Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
  3. Patient has appropriate femoral vein access
  4. Patient at risk for PE and meets at least one of the following sets of conditions:

    a. Documented DVT or PE and: i. Inability to anticoagulate the patient due to risk of bleeding such as recent surgery, trauma, intracranial bleed, GI bleed, OR ii. Progression/recurrence of DVT or PE on therapeutic anticoagulation, OR iii. Inability to anticoagulate due to high risk of tumor bleeding, OR iv. Patient unable to safely comply with anticoagulation, OR v. Patient that needs interruption of therapeutic anticoagulation such as at the time of an operation or other procedure.

    b. Patient that is high risk for DVT or PE and cannot be safely anticoagulated such as severe multi-trauma patient or patient having procedure with high risk for thromboembolism such as bariatric surgery.

    c. Patients with DVT at high risk for PE and free floating iliac or caval thrombosis d. Patients with compromised cardiopulmonary reserve from existing PE with right heart failure/strain who could not tolerate any further insult from new PE

Exclusion Criteria:

  1. Patient has any one of the following conditions:

    1. Thrombus in the iliac veins or the IVC that precludes access to appropriate placement of the Crux Filter
    2. Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC
    3. Known duplicated or left-sided IVC
    4. Known IVC transverse diameter at target lower renal ostia > 28mm or < 17mm
    5. Known extrinsic compression from abdominal or pelvic mass
    6. Known tumor thrombus involving the central venous system
    7. Uncontrolled sepsis, infection or persistent bacteremia
    8. Patient is at risk for septic pulmonary embolism
    9. Patient has an existing implanted filter in the IVC or superior vena cava (SVC) or underwent filter retrieval in previous 60 days.
    10. Patient has uncontrollable or active coagulopathy or known uncorrectable bleeding diathesis
    11. Patient has a condition that inhibits radiographic visualization of the IVC for post-deployment assessment
  2. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol (nickel-titanium)
  3. Patients unwilling or unable to comply with the protocol
  4. Patients with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated
  5. Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
  6. Patient is participating in another device or drug clinical trial or has participated in such trial in the 30 days prior to enrollment
  7. Investigator considers patient to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented)

Sites / Locations

  • Surgical Care Associates
  • Vascular Access Solutions

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm

Arm Description

Outcomes

Primary Outcome Measures

Technical Success Rate
All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism. Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2015
Last Updated
July 8, 2019
Sponsor
Volcano Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02394912
Brief Title
Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System
Official Title
Evaluation of the Technical Success of Intravascular Ultrasound (IVUS) Guided Vena Cava Filter (VCF) Placement Using the LUMIFI™ With Crux® VCF System (LUMIFI Clinical Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Unsatisfactory filter deployment in several cases
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Volcano Corporation

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll in phase consisting of 2 study subjects per site prior to enrollment into the primary treatment phase for primary analyses. The purpose of the roll in phase is to assure compliance with site training on the use of the investigational device and protocol workflow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Deep Vein Thrombosis
Keywords
vena cava filter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
vena cava filter implantation (LUMIFI with Crux VCF System)
Primary Outcome Measure Information:
Title
Technical Success Rate
Description
All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism. Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is >18 years of age. Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent Patient has appropriate femoral vein access Patient at risk for PE and meets at least one of the following sets of conditions: a. Documented DVT or PE and: i. Inability to anticoagulate the patient due to risk of bleeding such as recent surgery, trauma, intracranial bleed, GI bleed, OR ii. Progression/recurrence of DVT or PE on therapeutic anticoagulation, OR iii. Inability to anticoagulate due to high risk of tumor bleeding, OR iv. Patient unable to safely comply with anticoagulation, OR v. Patient that needs interruption of therapeutic anticoagulation such as at the time of an operation or other procedure. b. Patient that is high risk for DVT or PE and cannot be safely anticoagulated such as severe multi-trauma patient or patient having procedure with high risk for thromboembolism such as bariatric surgery. c. Patients with DVT at high risk for PE and free floating iliac or caval thrombosis d. Patients with compromised cardiopulmonary reserve from existing PE with right heart failure/strain who could not tolerate any further insult from new PE Exclusion Criteria: Patient has any one of the following conditions: Thrombus in the iliac veins or the IVC that precludes access to appropriate placement of the Crux Filter Known inadequate venous anatomy to allow insertion or retrieval of the filter from the IVC Known duplicated or left-sided IVC Known IVC transverse diameter at target lower renal ostia > 28mm or < 17mm Known extrinsic compression from abdominal or pelvic mass Known tumor thrombus involving the central venous system Uncontrolled sepsis, infection or persistent bacteremia Patient is at risk for septic pulmonary embolism Patient has an existing implanted filter in the IVC or superior vena cava (SVC) or underwent filter retrieval in previous 60 days. Patient has uncontrollable or active coagulopathy or known uncorrectable bleeding diathesis Patient has a condition that inhibits radiographic visualization of the IVC for post-deployment assessment Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol (nickel-titanium) Patients unwilling or unable to comply with the protocol Patients with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure) Patient is participating in another device or drug clinical trial or has participated in such trial in the 30 days prior to enrollment Investigator considers patient to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Jacobs, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgical Care Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Vascular Access Solutions
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System

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