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Ongoing Registry of Deep Venous Reconstructions

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ClinicalTrials.gov Identifier: NCT02650453
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment
Venous Thrombosis Procedure: Deep venous reconstruction

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Retrospective
Official Title: Ongoing Registry of Deep Venous Reconstructions
Study Start Date : September 2009
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2029

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Deep venous reconstruction
    PTA & stenting with/without endophlebectomy and/or arteriovenous fistula creation


Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650453


Contacts
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Contact: Mark A de Wolf, MD m.dewolf@maastrichtuniversity.nl

Locations
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Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands, 6202AZ
Contact: Mark A. de Wolf, MD    0031.43.3881547    m.dewolf@maastrichtuniversity.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: Cees Wittens, MD, PhD Maastricht University Medical Centre

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02650453     History of Changes
Other Study ID Numbers: OP-VE-01
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maastricht University Medical Center:
Stent
Angioplasty
Endophlebectomy

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases