Clinical trial NCT01158482: Filter Initial & Long Term Evaluation After Placement and Retrieval Registry
Official title: FILTER - Filter Initial & Long Term Evaluation After Placement and Retrieval (Including Laser-Assisted Retrieval) Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thromboembolism
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No specific criteria. Anyone who will be undergoing IVC Filter Placement/Retrieval will be eligible.

Brief summary: A prospective data registry for all patients who undergo IVC (Inferior Vena Cava) filter placement or retrieval at Stanford. Potential enrollees will already be undergoing the procedure. If patients are willing, they will be prospectively enrolled prior to the procedure. As part of the study, chart and clinical data reviews will be used to track patient progress and response to the treatment.

Detailed description: Patient clinical data will be used in a clinical registry. Before a patient is to undergo their initial procedure for filter placement/retrieval, we will approach them for consent to participate in the study. If patients consent, we will follow clinical data from the procedure, and perform prospective follow-up over time to track clinical response and effects of the placement or removal procedure.

Various real-world protocols involving advanced filter removal (including laser-assisted filter removal) will be investigated by conducting registry-based clinical trials.

Participants will only be enrolled if they will be undergoing an IVC (Inferior Vena Cava) filter placement/retrieval procedure.

Eligibility criteria: Inclusion Criteria:

* Participants are adults, 18 years old or older
* Participants will be undergoing a procedure to have an IVC filter placed or removed

Exclusion Criteria:

None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: William T Kuo MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuo WT, Doshi AA, Ponting JM, Rosenberg JK, Liang T, Hofmann LV. Laser-Assisted Removal of Embedded Vena Cava Filters: A First-In-Human Escalation Trial in 500 Patients Refractory to High-Force Retrieval. J Am Heart Assoc. 2020 Dec 15;9(24):e017916. doi: 10.1161/JAHA.119.017916. Epub 2020 Nov 30.
citation: Sheu AY, Hoang NS, Kesselman AJ, Liang T, Rosenberg JK, Kuo WT. Prophylactic IVC filter placement in bariatric surgery patients: results from a prospective filter registry. CVIR Endovasc. 2018;1(1):13. doi: 10.1186/s42155-018-0021-5. Epub 2018 Nov 15.
citation: Kuo WT, Odegaard JI, Rosenberg JK, Hofmann LV. Laser-Assisted Removal of Embedded Vena Cava Filters: A 5-Year First-in-Human Study. Chest. 2017 Feb;151(2):417-424. doi: 10.1016/j.chest.2016.09.029. Epub 2016 Oct 8.
citation: Kuo WT, Odegaard JI, Rosenberg JK, Hofmann LV. Excimer laser-assisted removal of embedded inferior vena cava filters: a single-center prospective study. Circ Cardiovasc Interv. 2013 Oct 1;6(5):560-6. doi: 10.1161/CIRCINTERVENTIONS.113.000665. Epub 2013 Sep 24.