Cook IVC Filter Study

Pulmonary Embolism Clinical Trial

— CIVC  

Official title:

Cook IVC Filter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046096
• Other study ID #: 12-018
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: August 9, 2019

Study information

• Verified date: January 2022
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: August 9, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Günther Tulip® Vena Cava Filter
Temporary or permanent filter placement for the prevention of pulmonary embolism
• Cook Celect® Vena Cava Filters
Temporary or permanent filter placement for the prevention of pulmonary embolism

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	The Royal Liverpool University Hospital	Liverpool	Meyerside
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Southampton General Hospital	Southampton	Hampshire
United States	Johns Hopkins University	Baltimore	Maryland
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	North Carolina Memorial Hospital	Chapel Hill	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	University of Florida Health - Shands	Gainesville	Florida
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	The Methodist Hospital - Smith Tower	Houston	Texas
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Miami Cardiac and Vascular Institute	Miami	Florida
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	OSF St. Francis/Peoria Radiology Research and Education Foundation	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Abrazo Arrowhead Campus	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Stony Brook Medicine	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Filter Retrieval Rate	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)	2 years
Primary	The Number of Participants With Technical Placement Success and With 12-month Freedom From New Symptomatic Pulmonary Embolism (PE) While a Filter is Indwelling.	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).	12 months
Primary	The Rate of 12-month Freedom From Major Adverse Events (MAEs)	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.	12 months
Primary	Supplemental Analysis to the Safety Endpoint: The Number of Participants With 12-month Freedom From Major Adverse Events (MAEs).	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.	12 months
Secondary	Rate of Technical Placement Success and 12-month Freedom From New Symptomatic PE While Filter is Indwelling	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).	12 months
Secondary	Rate of 12-month Freedom From Major Adverse Events for the Combined Patient Population (i.e., the Celect and Günther Tulip Strata)	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.	12 months
Secondary	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.	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.	12 months