ClotTriever Outcomes (CLOUT) Registry
Sponsor: |
Inari Medical, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS9359 |
U.S. Govt. ID: |
NCT03575364 |
Contact: |
Claudia Musat: (212) 342-4102 / cm2065@cumc.columbia.edu |
A research team at Columbia University Irving Medical Center is collecting information for a registry studying how safely and effectively the ClotTriever device works in treating patients at least 18 years old with Deep Vein Thrombosis (DVT), or blood clots in the vessels of the leg. The sponsor of this study, Inari Medical, Inc., is paying the research doctors and team to gather information for this registry. The ClotTriever is meant to pull blood clots out of your vessels through a narrow, flexible tube called a catheter. You may be eligible to be a part of the registry if you and your doctor have decided to try treating your DVT with a procedure using the ClotTriever. There is nothing experimental about this study. This research only involves data collection for a registry as you undergo the treatment for DVT that you would normally receive whether or not you were a part of this research. If you decide to be a part of this research, and are found eligible for it, you will be one of approximately 500 registry subjects from 50 different sites across the United States. The research team will collect information about your regular medical care before, during, immediately after, and for up to 2 years following your ClotTriever procedure. This information will include physical exam records, list of blood-thinning medications you are taking, examination of your surgery access site, ultrasound images, questionnaires about the quality of your daily life, and scales to rate the level of pain you are experiencing after the procedure. There will be 5 Follow-up visits for data collection - at discharge from the hospital after the procedure, and at 30 days, 6 months, 1 year, and 2 years after the procedure. If you would like to learn more about being on this registry, please contact the Research Manager, Claudia Musat, by phone at (212) 342-4102 or email her at cm2065@cumc.columbia.edu.
This study is closed
Investigator
Edvard Skripochnik, MD, RPVI
Are you at least 18 years old? |
Yes |
No |
Do you have Deep Vein Thrombosis (DVT)? |
Yes |
No |