Treadmill Pilot Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01846780
First received: May 1, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 after PTA & stenting of iliofemoral and iliocaval venous obstruction.

Study design: Prospective, observational study where patients are their own controls by making use of the waiting time for stenting with an extra test day (crossover study design).

Study population: Patients with an iliofemoral or iliocaval 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, circumference and flow of the common femoral vein just above the saphenofemoral junction 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).


Condition Intervention
Deep Venous Obstruction Lower Limb
Post-thrombotic Syndrome
May-Thurner Syndrome
Procedure: PTA & stenting

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • change in (ambulatory) venous pressure [ Time Frame: 0 months, 3months, 6 months ] [ Designated as safety issue: No ]
    measured at the dorsal foot vein and common femoral vein


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Venous outflow obstruction lower limb Procedure: PTA & stenting

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients at our specialized venous outpatient clinic in our tertiary centre

Criteria

Inclusion Criteria:

  • Indication for stenting, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846780

Locations
Netherlands
Maastricht University Medical Centre Not yet recruiting
Maastricht, Netherlands, 6202AZ
Contact: RLM Kurstjens, MD    +31433881558    r.kurstjens@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01846780     History of Changes
Other Study ID Numbers: NL44588
Study First Received: May 1, 2013
Last Updated: May 1, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Postthrombotic Syndrome
Postphlebitic Syndrome
May-Thurner Syndrome
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014