Clinical trial NCT02650453: Ongoing Registry of Deep Venous Reconstructions
Official title: Ongoing Registry of Deep Venous Reconstructions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Venous Thrombosis
Keywords: Stent
Angioplasty
Endophlebectomy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiënts undergoing deep venous reconstuctive interventions in cases of deep venous obstructive disease; such as (but not limited to) post-thrombotic syndrome and May-Thurner syndrome

Brief summary: Ongoing registration of deep venous obstructive disease patients treated by means of percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or arteriovenous fistula creation.

Detailed description: Literature has shown endovenous reconstructions to be safe en effective in treating deep venous obstructive disease. Deep venous obstruction can develop in cases of (iliac) vein compression syndromes (e.g. May-Thurner syndrome) or in cases of post-thrombotic syndrome. In patients with both significant complaints (objectively measured) and venous obstruction objectified on imaging (duplex ultrasonography, magnetic resonance venography, CT-venography) stenting is indicated.

In cases of extensive post-thrombotic damage to the veins of the lower extremity endophlebectomy (surgical desobstruction) of the common femoral vein can be warranted. This operation is generally combined with the creation of an arteriovenous fistula.

Data of patients treated in our tertiary medical centre are entered in a prospective digital database, and continuously updated.

Eligibility criteria: Inclusion Criteria:

* Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava

Exclusion Criteria:

* Intolerance to anticoagulant medication
* A life expectancy \<1 year

Primary outcomes:
measure: Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals.
timeFrame: 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Secondary outcomes:
measure: Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.
timeFrame: Baseline, 12 and 52 weeks post-intervention, and yearly thereafter.
measure: Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire.
timeFrame: Baseline, 3 and 12 months post-intervention and yearly afterwards
measure: Change in QoL, assessed by Venous Insufficiency Epidemiological and Economic Study-quality of life/symptoms scales (VEINES-QoL/sym).
timeFrame: Baseline, 3 and 12 months post-intervention and yearly afterwards
measure: Change in Venous Clinical Severity Score (VCSS).
timeFrame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
measure: Change in Villalta scale
timeFrame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
measure: Venous claudication; number of patients with presence or absence of venous claudication pre-intervention and post-intervention during follow-up.
timeFrame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Centre
name: Cees Wittens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: