Evaluation of the Technical Success of IVUS Guided VCF Placement Using the LUMIFI™ With Crux® VCF System
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single-arm
|
Device: vena cava filter implantation (LUMIFI with Crux VCF System)
|
Outcome Measures
Primary Outcome Measures
- Technical Success Rate [Day 1]
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.
Eligibility Criteria
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:
-
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.
-
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.
-
Patients with DVT at high risk for PE and free floating iliac or caval thrombosis
-
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
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Known extrinsic compression from abdominal or pelvic mass
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Known tumor thrombus involving the central venous system
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Uncontrolled sepsis, infection or persistent bacteremia
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Patient is at risk for septic pulmonary embolism
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Patient has an existing implanted filter in the IVC or superior vena cava (SVC) or underwent filter retrieval in previous 60 days.
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Patient has uncontrollable or active coagulopathy or known uncorrectable bleeding diathesis
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Patient has a condition that inhibits radiographic visualization of the IVC for post-deployment assessment
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Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol (nickel-titanium)
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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
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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)
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Patient is participating in another device or drug clinical trial or has participated in such trial in the 30 days prior to enrollment
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Surgical Care Associates | Louisville | Kentucky | United States | 40207 |
| 2 | Vascular Access Solutions | Orangeburg | South Carolina | United States | 29118 |
Sponsors and Collaborators
- Volcano Corporation
Investigators
- Principal Investigator: Donald Jacobs, MD, St. Louis University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 140201
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This was a prospective, single-arm, multicenter clinical study to evaluate the safety & effectiveness of the LUMIFI with Crux VCF system. The study included enrollment into a roll-in phase Cohort A consisting of 2 subjects/ site to assure compliance with the Investigational Device prior to enrolling into Cohort B, the treatment phase. |
| Arm/Group Title | LUMIFI With Crux VCF System |
|---|---|
| Arm/Group Description | vena cava filter implantation (LUMIFI with Crux VCF System). Includes both Cohort A and Cohort B subjects. |
| Period Title: Overall Study | |
| STARTED | 21 |
| COMPLETED | 21 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | LUMIFI With Crux VCF System |
|---|---|
| Arm/Group Description | vena cava filter implantation (LUMIFI with Crux VCF System) |
| Overall Participants | 21 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
8
38.1%
|
| >=65 years |
13
61.9%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
21
100%
|
| Region of Enrollment (participants) [Number] | |
| United States |
21
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | LUMIFI With Crux VCF System | Cohort A | Cohort B |
|---|---|---|---|
| Arm/Group Description | vena cava filter implantation (LUMIFI with Crux VCF System) | Roll-in phase consisting of 2 subjects per site to assure compliance with use of the Investigational Device | Subjects are enrolled into Cohort B after each site has enrolled 2 subjects in Cohort A to assure compliance with use of the Investigational Device |
| Measure Participants | 21 | 8 | 13 |
| Count of Participants [Participants] |
16
76.2%
|
6
NaN
|
10
NaN
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | LUMIFI With Crux VCF System | |
| Arm/Group Description | vena cava filter implantation (LUMIFI with Crux VCF System) | |
All Cause Mortality |
||
| LUMIFI With Crux VCF System | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| LUMIFI With Crux VCF System | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| LUMIFI With Crux VCF System | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/21 (9.5%) | |
| Vascular disorders | ||
| Pulmonary Emboli Bilaterial | 1/21 (4.8%) | 1 |
| Filter deployed too low | 1/21 (4.8%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Principal Investigator shall have the right to publish or otherwise make public any data resulting from the study upon the earlier of (a) publication of a multi-center publication (or any publication, if the Study is not a multi-center study) coordinated by Sponsor with respect to the data resulting from the study, and (b) eighteen (18) months after the Study is completed at all participating sites if a multi-center publication.
Results Point of Contact
| Name/Title | VP Clinical Trials |
|---|---|
| Organization | Volcano |
| Phone | 858-720-8731 |
| jonathan.batiller@philips.com |
- 140201