Treadmill pilot study.
- Conditions
- post-thrombotic syndrome, PTS, May-Thurner syndrome, MTS, venous claudication, outflow obstruction, deep venous obstruction, stenting, stent, deep venous thrombosis, DVT
- Registration Number
- NL-OMON26641
- Lead Sponsor
- Maastricht University Medical Centre+
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Indication for stenting;
2. Minimally 18 years of age;
Exclusion Criteria
1. Younger than 18 years of age;
2. Life expectancy of less than 6 months;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main endpoint is the change in (ambulatory) venous pressure, measured at the dorsal foot vein and common femoral vein. This will be expressed in millimetres mercury.
- Secondary Outcome Measures
Name Time Method There are various secondary endpoints. Change in pain free walking distance and maximum walking distance will be expressed in both time and distance. Change in diameter/circumference, transverse surface area and flow of the common femoral vein will be expressed in millimetres, square millimetres and millilitres per second, respectively. Furthermore change in CEAP, Villalta score, venous clinical severity score and generic and disease specific quality of life scores will be assessed. Finally, patency will be assessed.