Treadmill Pilot Study (Invasive Pressure Measurements in PTS)

October 20, 2015 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202AZ
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients at our specialized venous outpatient clinic in our tertiary centre

Description

Inclusion Criteria:

  • Indication for stenting (possibly with endophlebectomy and AV-fistula), minimally 18 years of age, life expectancy of at least 6 months.

Exclusion Criteria:

  • Younger than 18 years of age, life expectancy of less than 6 months, venous obstruction in the contralateral limb, peripheral arterial disease, pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Procedure: PTA & stenting
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in (ambulatory) venous pressure
Time Frame: 0 months, 3months
measured at the dorsal foot vein and common femoral vein
0 months, 3months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
VCSS
Time Frame: 0 months, 3months
0 months, 3months
Villalta scale
Time Frame: 0 months, 3months
0 months, 3months
Quality of Life
Time Frame: 0 months, 3months
0 months, 3months
Patency
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cees Wittens, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL44588

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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