Post-thrombotic SyndromeNCT01846780
Treadmill Pilot Study (Invasive Pressure Measurements in PTS)
An observational study of Post-thrombotic Syndrome and May-Thurner Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-thrombotic Syndrome, May-Thurner Syndrome
- What is being tested?
- PTA & stenting
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at our specialized venous outpatient clinic in our tertiary centre
Who may be able to join
- Indication for stenting (possibly with endophlebectomy and AV-fistula), minimally 18 years of age, life expectancy of at least 6 months.
Who cannot join
- Younger than 18 years of age, life expectancy of less than 6 months, venous obstruction in the contralateral limb, peripheral arterial disease, pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of PTA & Stenting on Intravenous Pressure in Deep Venous Obstructive Disease Before, After and During Ambulation on a Treadmill - Pilot Study.
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.
Read the detailed description
Rationale: PTA \& stenting in iliofemoral and iliocaval venous obstruction has been proven to be an effective method of treatment with good clinical results. However, no proper investigations have been made to objectify the reduction in (ambulatory) venous hypertension caused by this type of obstruction. Normal ambulatory venous pressure is below 20mmHg, though studies have already shown a linear relationship between the incidence of ulcers and an ambulatory intravenous pressure of more than 30mmHg. We believe that by measuring the (ambulatory) venous pressure before and after stenting, we will gain more knowledge on the hemodynamics of venous disease and its treatment and we will obtain information that might identify patients at risk of stent occlusion or the forming of an ulcer in an early stage. Identifying these patients will most certainly influence preventive treatment in the future.
Objective: To map the changes in intravenous pressure in post-thrombotic iliofemoral venous obstruction and evaluate the effect of PTA \& stenting with possible identification of a predictive parameter for success of treatment.
Study design: Prospective, observational study (healthy and diseased limb in one patient).
Study population: Patients with an iliofemoral venous obstruction, objectified on duplex ultrasonography and magnetic resonance venography, and the indication for stenting of the obstructed tract(s).
Intervention: All patients will undergo stenting of the obstructed venous tract. Patients receive the same therapy as they would have received not participating in this study; therefore this study has no influence on the treatment patients receive.
Main study parameters/endpoints: Primary outcome is the change in (ambulatory) venous pressure after stenting for deep venous obstructive disease. Other important endpoints are the absolute values for intravenous pressure, pain free walking distance and maximum walking distance. Additional outcome measurements are stent patency, CEAP score, Villalta score, venous clinical severity score, and generic and disease specific quality of life scores. Finally, transverse surface area, diameter and circumference of the common femoral vein will be measured.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients have to make three visits. Each visit will take approximately two hours. During each test day, patients will undergo intravenous pressure measurements in both dorsal foot veins, both common femoral veins and a vein in the left upper arm, which are measured via a venflon needle or microsheath (placed under ultrasound guidance) connected to a pressure transducer; a treadmill test lasting maximally 26 minutes; an air plethysmography, which they need to undergo anyway; and a duplex ultrasound to assess the common femoral vein. This is a very low risk study, since all diagnostic tools that are used or also used in usual clinical practice and given the low risk on mild complications. Patients can experience pain due to the insertion and removal of the venflons/microsheaths, due to compression of the groin after removal of the microsheaths and due to walking on a treadmill (because of venous claudication).
Amendment:
iv in the arm vein as a control is not performed anymore. An abdominbal wall collateral is cannulated instead, if present.
- Conditions
- Post-thrombotic Syndrome, May-Thurner Syndrome
- Being tested
- PTA & stenting
- Medical subject headings
- Postthrombotic Syndrome, May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA & stentingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: PTA & stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in (ambulatory) venous pressure
measured at the dorsal foot vein and common femoral vein
Measured: 0 months, 3months
Secondary outcomes (4)
VCSS
Measured: 0 months, 3months
Villalta scale
Measured: 0 months, 3months
Quality of Life
Measured: 0 months, 3months
Patency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-thrombotic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Wittens, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846780
- Sponsor's protocol ID
- NL44588
- Status last verified
- Oct 2015
- First submitted
- 1 May 2013
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27061685
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PTA & Stenting on Intravenous Pressure in Deep Venous Obstructive Disease Before, After and During Ambulation on a Treadmill - Pilot Study.
- ClinicalTrials.gov ID
- NCT01846780
- Acronym / sponsor ID
- NL44588
- Conditions
- Post-thrombotic Syndrome, May-Thurner Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: PTA \& stenting in iliofemoral and iliocaval venous obstruction has been proven to be an effective method of treatment with good clinical results. However, no proper investigations have been made to objectify the reduction in (ambulatory) venous hypertension caused by this type of obstruction. Normal ambulatory venous pressure is below 20mmHg, though studies have already shown a linear relationship between the incidence of ulcers and an ambulatory intravenous pressure of more than 30mmHg. We believe that by measuring the (ambulatory) venous pressure before and after stenting, we will gain more knowledge on the hemodynamics of venous disease and its treatment and we will obtain information that might identify patients at risk of stent occlusion or the forming of an ulcer in an early stage. Identifying these patients will most certainly influence preventive treatment in the future.
Objective: To map the changes in intravenous pressure in post-thrombotic iliofemoral venous obstruction and evaluate the effect of PTA \& stenting with possible identification of a predictive parameter for success of treatment.
Study design: Prospective, observational study (healthy and diseased limb in one patient).
Study population: Patients with an iliofemoral venous obstruction, objectified on duplex ultrasonography and magnetic resonance venography, and the indication for stenting of the obstructed tract(s).
Intervention: All patients will undergo stenting of the obstructed venous tract. Patients receive the same therapy as they would have received not participating in this study; therefore this study has no influence on the treatment patients receive.
Main study parameters/endpoints: Primary outcome is the change in (ambulatory) venous pressure after stenting for deep venous obstructive disease. Other important endpoints are the absolute values for intravenous pressure, pain free walking distance and maximum walking distance. Additional outcome measurements are stent patency, CEAP score, Villalta score, venous clinical severity score, and generic and disease specific quality of life scores. Finally, transverse surface area, diameter and circumference of the common femoral vein will be measured.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients have to make three visits. Each visit will take approximately two hours. During each test day, patients will undergo intravenous pressure measurements in both dorsal foot veins, both common femoral veins and a vein in the left upper arm, which are measured via a venflon needle or microsheath (placed under ultrasound guidance) connected to a pressure transducer; a treadmill test lasting maximally 26 minutes; an air plethysmography, which they need to undergo anyway; and a duplex ultrasound to assess the common femoral vein. This is a very low risk study, since all diagnostic tools that are used or also used in usual clinical practice and given the low risk on mild complications. Patients can experience pain due to the insertion and removal of the venflons/microsheaths, due to compression of the groin after removal of the microsheaths and due to walking on a treadmill (because of venous claudication).
Amendment:
iv in the arm vein as a control is not performed anymore. An abdominbal wall collateral is cannulated instead, if present.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous outflow obstruction lower limb | – | Procedure: PTA & stentingPatients with unilateral post-thrombotic iliac vein/common femoral vein obstruction undergoing PTA \& stenting (possibly with additional endophlebectomy and AV-fistula) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at our specialized venous outpatient clinic in our tertiary centre
Key inclusion criteria (1 listed)
- Indication for stenting (possibly with endophlebectomy and AV-fistula), minimally 18 years of age, life expectancy of at least 6 months.
Key exclusion criteria (1 listed)
- Younger than 18 years of age, life expectancy of less than 6 months, venous obstruction in the contralateral limb, peripheral arterial disease, pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTA & stentingPTA \& 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. | Procedure or surgery | Venous outflow obstruction lower limb |
Primary outcome
change in (ambulatory) venous pressure
Time frame: 0 months, 3months
measured at the dorsal foot vein and common femoral vein
4 secondary outcomes
VCSS
Time frame: 0 months, 3months
Villalta scale
Time frame: 0 months, 3months
Quality of Life
Time frame: 0 months, 3months
Patency
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Derived from this study: PubMed 27061685Kurstjens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cees Wittens, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-thrombotic Syndrome and May-Thurner Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in (ambulatory) venous pressure (time frame: 0 months, 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.