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Treadmill pilot study.

The effect of PTA & stenting on intravenous pressure in deep venous obstructive disease before, after and during ambulation on a treadmill – Pilot study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26641
Enrollment
20
Registered
2013-04-15
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-thrombotic syndrome, PTS, May-Thurner syndrome, MTS, venous claudication, outflow obstruction, deep venous obstruction, stenting, stent, deep venous thrombosis, DVT

Interventions

PTA & stenting.

Sponsors

Maastricht University Medical Centre+
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indication for stenting; 2. Minimally 18 years of age; 3. Life expectancy of at least 6 months.

Exclusion criteria

Exclusion criteria: 1. Younger than 18 years of age; 2. Life expectancy of less than 6 months; 3. Venous obstruction in the contralateral limb; 4. Peripheral arterial disease; 5. Pregnancy.

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
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.

Contacts

Public ContactR.L.M. Kurstjens

Maastricht University Medical Centre+ Department of Surgery PO Box 5800

r.kurstjens@maastrichtuniversity.nl+31 (0)43 3881558

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)