Excimer Laser Assisted IVC Filter Retrieval
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02240251|
Recruitment Status : Recruiting
First Posted : September 15, 2014
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment|
|IVC Filters||Other: Prospective Chart Review|
At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed >95%. Technical failures, although rare, are usually related to excessive endoluminal scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques are often employed in difficult cases. The excimer laser sheath has been successfully used at Northwestern for patients who had failed all other retrieval techniques.
Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will be consented to participate in the chart review study and become a part of a registry kept at Northwestern Memorial Hospital. The procedure itself is not being used as part of the study. Chart reviews will be completed and data collected on the procedure to remove the filter. Follow up after the procedure by phone call and chart review will be completed at least once, 1 week after the filter removal.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Weeks|
|Official Title:||A Prospective Review of Excimer Laser Assisted Inferior Vena Cava (IVC) Filter Retrieval|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients undergoing IVC filter removal using the excimer laser
Laser Assisted IVC Filter Removal
Other: Prospective Chart Review
The laser assisted IVC filter removal procedure itself is not part of this study. This is a prospective chart review for patients undergoing this procedure.
- Evaluate any adverse events related to laser assisted IVC filter removal [ Time Frame: up to 1 year after Laser Assited IVC filter removal ]The number and severity of adverse events will be recorded to evaluate safety. This will be conducted as a phone call to the patient 1 week after IVC filter removal and then as a chart review only.
- Effectiveness of Laser Assisted IVC filter removal [ Time Frame: At time of IVC filter removal ]Success rate of removing IVC filters using the laser will be recorded. If a filter cannot be removed with the laser the reason for this failure will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240251
|Contact: Jennifer Karp, RN BSNemail@example.com|
|Contact: Robert Lewandowski, MDfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Jennifer Karp, RN BSN 312-926-5289 email@example.com|
|Contact: Kush Desai, MD 312-926-5289 firstname.lastname@example.org|
|Principal Investigator: Robert Lewandowski, MD|
|Sub-Investigator: Kush Desai, MD|
|Sub-Investigator: Mark Eskandari, MD|
|Principal Investigator:||Robert Lewandowski, MD||Northwestern University|