Venous Thrombo-embolism Clinical Trial
Official title:
IVC Filter Study to Monitor and Measure Patients Outcomes Through Standardized Collection and Analysis of Clinical Information
| Verified date | June 2013 |
| Source | American Venous Forum |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. While there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.
| Status | Terminated |
| Enrollment | 20000 |
| Est. completion date | May 2014 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Data obtained in line with good clinical practice,applicable laws and regulation |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwest Texas Hospital | Amarillo | Texas |
| United States | University Of Michigan Health System | Ann Arbor | Michigan |
| United States | St. Luke's Medical Center | Chesterfield | Missouri |
| United States | University of Chicago Hospitals | Chicago | Illinois |
| United States | Good Samaritan Hospital | Cincinnati | Ohio |
| United States | Palmetto Health and Providence Hospital | Columbia | South Carolina |
| United States | Exempla Lutheran Medical Center | Denver | Colorado |
| United States | Doylestown Hospital | Doylestown | Pennsylvania |
| United States | University of Florida , Division of Vascular Surgery & Endovascular Therapy | Gainesville | Florida |
| United States | University of Texas Medical Branch | Galveston | Texas |
| United States | Vascular Health Alliance, Greenville Hospital System | Greenville | South Carolina |
| United States | St Peters Hospital | Helena | Montana |
| United States | Eastern Idaho Regional Medical Center | Idaho Falls | Idaho |
| United States | Lancaster General Hospital | Lancaster | Pennsylvania |
| United States | University Of Kentucky , Vascular and Endovascular Divison | Lexington | Kentucky |
| United States | Medical Center of Central Georgia | Macon | Georgia |
| United States | West Virginia University Healthcare | Morgantown | West Virginia |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Tuoro Infirmary | New Orleans | Louisiana |
| United States | Brooklyn Hospital | New York | New York |
| United States | University of Pittsburgh School of Medicine Division of Vascular Surgery | Pittsburgh | Pennsylvania |
| United States | University Of Rochester Medical Center | Rochester | New York |
| United States | Southern Illinois University School of Medicine | Springfield | Illinois |
| United States | Bayfront Medical Center | St Petersburg | Florida |
| United States | Stony Brook University Medical Center, Vein Clinic | Stony Brook | New York |
| United States | Jobst Vascular Institute | Toledo | Ohio |
| United States | Avera Sacred Heart Hospital | Yankton | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| American Venous Forum |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Integrity of IVC Filter 12 months post placement | 48 Months | Yes |