Clinical trial NCT00654979: A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
Official title: A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: RMT Medical Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.


Eligibility criteria: Inclusion Criteria:

* Traditional indications for vena cava filter in patients with established DVT or PE, including (40):

  * Patients with proven Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) and one or more of the following:

    1. Contraindication to anticoagulation
    2. Complication of anticoagulation
    3. Failure of anticoagulation

       * Recurrent PE despite adequate anticoagulation therapy
       * Inability to achieve adequate anticoagulation
    4. Poor compliance with anticoagulation medications
* Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):

  * Large free-floating thrombus in the iliac vein or IVC;
  * Following massive PE in which recurrent emboli may prove fatal;
  * During/after surgical or transcatheter embolectomy;
  * Filter placement in high-risk trauma and orthopedic patients:
* High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40):

  1. Severe closed head injury (GCS \< 8);
  2. Incomplete spinal cord injury with para or quadriplegia;
  3. Complex pelvic fractures with associated long-bone fractures;
  4. Multiple long bone fractures.
* Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)

Exclusion Criteria:

* All patients under 18 years of age.
* All patients undergoing emergency procedures.
* All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation.
* All patients with an IVC diameter which precludes oversizing of the filter platform.
* All patients with active infection / bacteremia.
* All patients with sensitivity to contrast media.
* Uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).

Primary outcomes:
measure: Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization.
timeFrame: 6 months follow-up
Secondary outcomes:
measure: The proportion of patients with successful deployment of the filter will be calculated and presented with a 95% exact confidence interval.
timeFrame: 3 and 6 months follow-up
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Manhattan
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Athens
country: Greece
facility: 251 Air Force Hospital
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Bloemfontein
country: South Africa
facility: Universitas Hospital
city: Dumfermline
country: United Kingdom
facility: Queen Margaret Hospital
state: Scotland
Study officials:
affiliation: Montefiore Medical Center
name: Jacob Cynamon, Dr.
role: PRINCIPAL_INVESTIGATOR
References: