Treadmill Pilot Study (Invasive Pressure Measurements in PTS)
The Effect of PTA & Stenting on Intravenous Pressure in Deep Venous Obstructive Disease Before, After and During Ambulation on a Treadmill - Pilot Study.
1 other identifier
observational
24
1 country
1
Brief Summary
Patients with unilateral post-thrombotic obstruction of the iliac tract and or common femoral vein, eligible for stenting are included. Intravenous pressure is measured in both dorsal foot veins and both common femoral veins. Patients are asked to undergo a standardised treadmill test (3.2km/h, 0% slope that increases by 2%/2min, maximum walking time 26 min). Painfree and maximum action radius are noted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 21, 2015
October 1, 2015
1.5 years
May 1, 2013
October 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
change in (ambulatory) venous pressure
measured at the dorsal foot vein and common femoral vein
0 months, 3months
Secondary Outcomes (4)
VCSS
0 months, 3months
Villalta scale
0 months, 3months
Quality of Life
0 months, 3months
Patency
3 months
Study Arms (1)
Venous outflow obstruction lower limb
Patients with unilateral post-thrombotic iliac vein/common femoral vein obstruction undergoing PTA \& stenting (possibly with additional endophlebectomy and AV-fistula)
Interventions
PTA \& stenting of the iliac veins and/or common femoral vein. Patients who need to undergo endophlebectomy of the common femoral vein with AV-fistula creation are also included.
Eligibility Criteria
Patients at our specialized venous outpatient clinic in our tertiary centre
You may qualify if:
- Indication for stenting (possibly with endophlebectomy and AV-fistula), minimally 18 years of age, life expectancy of at least 6 months.
You may not qualify if:
- Younger than 18 years of age, life expectancy of less than 6 months, venous obstruction in the contralateral limb, peripheral arterial disease, pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University Medical Centre
Maastricht, 6202AZ, Netherlands
Related Publications (1)
Kurstjens RL, de Wolf MA, Konijn HW, Toonder IM, Nelemans PJ, de Graaf R, Wittens CH. Intravenous pressure changes in patients with postthrombotic deep venous obstruction: results using a treadmill stress test. J Thromb Haemost. 2016 Jun;14(6):1163-70. doi: 10.1111/jth.13333. Epub 2016 May 31.
PMID: 27061685DERIVED
Biospecimen
Blood samples for possible future research
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cees Wittens, MD, PhD
Maastricht University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
December 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 21, 2015
Record last verified: 2015-10