Crux Biomedical IVC Filter - Evaluation of the Crux Inferior Vena Cava Filter System (Retrieve)

NCT ID: NCT00605332

Last Updated: 2012-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-07-31

Brief Summary

This is an open label, non-randomized, prospective, multicenter study.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Investigative Device (Crux Biomedical IVC Filter) will be evaluated for its ability to capture thrombus for the prevention of pulmonary embolism.

Group Type: EXPERIMENTAL

inferior vena cava filter

Intervention Type: DEVICE

Crux Biomedical IVC Filter

Interventions

inferior vena cava filter

Crux Biomedical IVC Filter

Intervention Type: DEVICE

Other Intervention Names

No other names

Eligibility Criteria

Inclusion Criteria

1. The patient is >18 years of age.

2. Patient is considered a candidate for the IVCF under one of the following indications:

• Proven PE
• Recurrent PE despite adequate anticoagulation
• Contraindication to anticoagulation
• Inability to achieve/maintain therapeutic anticoagulation
• Iliocaval DVT
• Large, free-floating proximal (i.e. ileofemoral) DVT
• Massive PE treated with thrombolysis/thrombectomy
• Chronic PE treated with thrombectomy
• Protection during thrombolysis for iliocaval DVT
• PE with limited cardiopulmonary reserve
• Poor compliance with anticoagulant medications
• High risk of injury worsened by anticoagulation (e.g., ataxia, falls)
• Multi-trauma patient with high risk of PE
• Surgical patients at high risk of PE
• Medical condition with high risk of PE

3. Patient has a vena cava diameter of 17-28mm.

4. The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.

5. The patient is willing to be available for the appropriate follow-up for the duration of the study.

6. The patient has suitable IVC anatomy that would allow infra-renal placement of the filter.

Exclusion Criteria

1. The patient has one of the following conditions:

• Renal vein thrombosis
• IVC thrombosis extending to renal veins
• Duplicate IVC
• Gonadal vein thrombosis
• Requires supra-renal filter placement

2. The patient has an uncontrolled infectious disease.

3. The patient is at risk for aseptic PE.

4. Patient has uncontrollable coagulopathy.

5. Patient has an existing IVCF.

6. The patient has a life expectancy of less than 6 months.

7. The patient is pregnant.

8. The patient has a condition that inhibits radiographic visualization of the IVC.

9. The patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol.

10. The patient has a known hypersensitivity to contrast which cannot be pre-treated.

11. The patient's access vessels preclude safe insertion of the delivery system.

12. The patient is participating in another device or drug study. Patient must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this trial. The patient may only be enrolled in this study once.

13. The patient is unable and/or unwilling to cooperate with study procedures or required follow-up visits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crux Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Vascular Specialists

Mel Schatz

Role: STUDY_DIRECTOR

Crux Biomedical

Countries

United States

Other Identifiers

G070035

Identifier Type: -

Identifier Source: secondary_id

RETRIEVE I

Identifier Type: -

Identifier Source: org_study_id