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Completed

NCT Number: NCT02046096

Cook IVC Filter Study

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred Hospital, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Requires temporary or permanent IVC filter placement for the prevention of PE

Exclusion criteria

  • Less than 18 years of age
  • Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
  • Known allergy or sensitivity to cobalt, chromium, or nickel
  • Pregnant or planning to become pregnant in the next 12 months
  • Patient refuses blood transfusions
  • At risk of septic embolism
  • Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
  • Existing IVC filter
  • Duplicate IVC
  • Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
  • IVC diameter > 30 mm or < 15 mm

Treatment and study plan

Günther Tulip® Vena Cava Filter

Device

Temporary or permanent filter placement for the prevention of pulmonary embolism

Cook Celect® Vena Cava Filters

Device

Temporary or permanent filter placement for the prevention of pulmonary embolism

Primary outcomes

  1. The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.

    Time frame: 12 months

    The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).

  2. The Rate of 12-month Freedom From Major Adverse Events (MAEs)

    Time frame: 12 months

    MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.

    Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT.

    Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention.

    Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.

  3. Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).

    Time frame: 12 months

    MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.

    A filter retrieval is considered a successful safety result through 12 months, regardless of when the retrieval occurred.

Secondary outcomes

  1. Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling

    Time frame: 12 months

    Rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling for the combined patient population (i.e., the Celect and Günther Tulip strata).

    The protocol defined technical placement success as: deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration (caudal or cranial movement of a filter resulting in a surgical or endovascular intervention).

  2. Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)

    Time frame: 12 months

    MAEs were defined as clinical perforation, clinical migration, clinical fracture, embolization of the filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, new symptomatic DVT while the filter is indwelling, access site complications with clinical sequelae, and procedure-/device-related death.

    Clinical perforation - Protrusion of filter legs through the wall of the IVC causing hemorrhage or hematoma or touching, impressing, or perforating another organ. Documented using CT.

    Clinical migration - Caudal or cranial movement of a filter resulting in surgical or endovascular intervention.

    Clinical fracture - A loss of structural integrity (breakage or separation) of the filter identified by imaging and associated with clinical sequelae and/or requiring intervention.

  3. Number of Participants With Freedom From Grade 2 or Grade 3 Filter Leg Interaction With IVC, Filter Migration, Filter Fracture, and Filter Embolization at 12-month.

    Time frame: 12 months

    Filter interaction with IVC is defined as :

    Grade 2: Filter strut is entirely outside of the IVC lumen and within the retroperitoneum as evidenced by a "halo" of retroperitoneal fat around axially viewed strut.

    Grade 3: Filter strut is touching, impressing, or perforating another organ (e.g., liver, bowel, aorta, psoas muscle, vertebral body, lymph nodes).

    Filter migration : Change in filter position compared to its deployed position (cranial or caudal).

    Filter fracture : Any loss of structural integrity (breakage or separation) of the filter identified by imaging or autopsy. Documented by imaging or at autopsy.

    Filter embolization : Post-placement movement of the filter or its components to a distant anatomic site completely out of the target zone (i.e., heart/lungs). Documented by imaging or autopsy.

Other outcomes

  1. Filter Retrieval Rate

    Time frame: 2 years

    The filters may be retrieved if clinically indicated. The IVC filter and IVC were assessed on imaging before a retrieval attempt.

    (The filter retrieval rate= the total number of filter retrieved / the total number of filter retrieval attempted)

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Acronym: CIVC

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jan 27, 2014
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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