To improve our understanding on the etiology of proximal DVTs, to identify risk factors for stent reinterventions and to optimize treatment after a venous stent. To improve patient education and expectation after a venous stent.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Vascular therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patency rates of venous stents and predictors for reinterventions or occlusions
Secondary outcomes: prevalence of coagulation disorders in the study
population, comparison of coagulation disorders between patients with MT
syndrome and right sided or distal DVTs, and quality of life (SF-36 and
CIVIQ-20).
Secondary outcome
Prevalence of coagulation disorders in the study population, comparison of
coagulation disorders between patients with MT syndrome and right sided or
distal DVTs, and quality of life (SF-36 and CIVIQ-20).
Background summary
Patients with a proximal DVT will develop PTS more often than patients with a
distal DVT. Venous stents are found to decrease the risk of PTS in the acute
phase, and to lower the symptoms of PTS in the chronic phase. Whether the
etiology of a proximal left sided DVT is mainly mechanical (May-Thurner
syndrome) or can be addressed to coagulation disorders is unknown. Data are
also lacking on risk factors for stent occlusions and quality of life after a
venous stent.
Study objective
To improve our understanding on the etiology of proximal DVTs, to identify risk
factors for stent reinterventions and to optimize treatment after a venous
stent. To improve patient education and expectation after a venous stent.
Study design
Retrospective cohort study and a nested case-control study.
Study burden and risks
No risks are associated with participation. If data on coagulation disorders or
imaging is missing, patients are asked to come in once for the collection of a
blood sample and/or a duplex ultrasound of the stent. The QOL questionnaires
are asked to be filled out once..
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Venous stent placement between 2006 and 2020 at the EMC in the common femoral
vein, iliac veins and/or inferior vena cava
- Signed informed consent
- Patients aged 18 years and older
- Sufficient understanding of the Dutch language.
Exclusion criteria
- Non-dedicated venous stents
- No follow-up due to death shortly after stent placement from a malignancy
(some stents were used for comfort care)
- Insufficient understanding of the Dutch language
- No informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74001.078.20 |