May-Thurner Syndrome Clinical Trial
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.
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.
;
Observational Model: Case Control, Time Perspective: Prospective
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