Ongoing Registry of Deep Venous Reconstructions
ConditionVenous Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava
Disqualifiers
Intolerance to anticoagulant medication
A life expectancy <1 year
Trial 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
Trial design
Time perspective
Retrospective
Treatments tested in this trial
Deep venous reconstruction
Procedure/SurgeryPTA \& stenting with/without endophlebectomy and/or arteriovenous fistula creation
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals.
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.
Time frame
2, 6, 12, 23, 52 weeks post-intervention and yearly afterwardsSecondary outcomes
1
Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.
The SF-36 is a generic QoL questionnaire.
Time frame
Baseline, 12 and 52 weeks post-intervention, and yearly thereafter.2
Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire.
The EQ-5D is a generic QoL questionnaire.
Time frame
Baseline, 3 and 12 months post-intervention and yearly afterwards3
Change in QoL, assessed by Venous Insufficiency Epidemiological and Economic Study-quality of life/symptoms scales (VEINES-QoL/sym).
The VEINES-QoL/sym is a disease-specific QoL questionnaire aimed at venous disease.
Time frame
Baseline, 3 and 12 months post-intervention and yearly afterwards4
Change in Venous Clinical Severity Score (VCSS).
The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.
Time frame
Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwardsSponsors and contacts
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Source ClinicalTrials.gov