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NCT Number: NCT02650453

Ongoing Registry of Deep Venous Reconstructions

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.

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Key information

Conditions

Venous Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Centre

Maastricht, 6202AZ, Netherlands

Location status: Recruiting

Location contact

Mark A. de Wolf, MD

CONTACT

[email protected]

0031.43.3881547

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep venous reconstruction

Procedure

PTA & stenting with/without endophlebectomy and/or arteriovenous fistula creation

Primary outcomes

  1. Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals.

    Time frame: 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards

    Patency is defined as the presence of bloodflow as imaged by use of duplex ultrasonography. Patency will be divided in 3 subgroups; primary patency, assisted primary patency and secondary patency.

    Primary patency is defined as presence of bloodflow during follow-up without any interventions undertaken to preserve or reclaim the openness of the treated vein segments.

    Assisted primary patency is defined as the presence of bloodflow during follow-up after use of an intervention to preserve the openness of the treated vein segments.

    Secondary patency is defined as the presence of bloodflow during follow-up after use of an intervention to reclaim the openness of the treated vein segments.

Secondary outcomes

  1. Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.

    Time frame: Baseline, 12 and 52 weeks post-intervention, and yearly thereafter.

    The SF-36 is a generic QoL questionnaire.

  2. Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire.

    Time frame: Baseline, 3 and 12 months post-intervention and yearly afterwards

    The EQ-5D is a generic QoL questionnaire.

  3. Change in QoL, assessed by Venous Insufficiency Epidemiological and Economic Study-quality of life/symptoms scales (VEINES-QoL/sym).

    Time frame: Baseline, 3 and 12 months post-intervention and yearly afterwards

    The VEINES-QoL/sym is a disease-specific QoL questionnaire aimed at venous disease.

  4. Change in Venous Clinical Severity Score (VCSS).

    Time frame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards

    The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.

  5. Change in Villalta scale

    Time frame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards

    The Villalta scale is a validated scoring system for assessing signs, symptoms and complaints of the post-thrombotic syndrome.

  6. Venous claudication; number of patients with presence or absence of venous claudication pre-intervention and post-intervention during follow-up.

    Time frame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards

    Venous claudication is the pain which develops in patients with obstructive-type venous disease during ambulation and other types of exercise, and which typically subsides when the patient rests in a lying down position or when sitting with elevation of the lower extremity. It is one of the clinically most important symptoms of (obstructive) venous disease. There is currently no validated or internationally accepted scoring system available. We will therefore note the presence of this typical symptom before treatment, and at regular intervals post-intervention (i.e. 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards).

Study contacts

Contact information is provided by the study sponsor or research team.

Mark A de Wolf, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2019
Study completion
2029
First posted
Jan 8, 2016
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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