Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251771
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2005-11-09
Brief Title:
Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Catheter-directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis an Open Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaVenT
Brief Summary:
Deep vein thrombosis DVT is a severe disease and conventional treatment with low molecular weight heparin LMWH and warfarin is associated with some degree of long-term sequelae ie post-thrombotic syndrome PTS Catheter-directed thrombolytic CDT therapy has been introduced worldwide the last two decades Reports have suggested a beneficial effect of this costly treatment but there are no randomized clinical trials documenting its short- and long-term efficacy and safety This multi-center study will randomize patients with acute iliofemoral vein thrombosis to either conventional treatment or CDT in addition to conventional treatment Main outcome parameters are patency rates at 6 months and prevalence of PTS at 24 months The main short-term hypothesis is that CDT of first-time acute DVT will increase patency of the affected segments after 6 months from 50 to 80 The main long-term hypothesis is that CDT will improve long-term functional outcome ie risk of PTS after 2 years from 25 to 10
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT No2005-004486-42 | None | None | None |