Ongoing Registry of Deep Venous Reconstructions
- Conditions
- Venous Thrombosis
- Registration Number
- NCT02650453
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava
- Intolerance to anticoagulant medication
- A life expectancy <1 year
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals. 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
Name Time Method Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey. Baseline, 12 and 52 weeks post-intervention, and yearly thereafter. The SF-36 is a generic QoL questionnaire.
Change in QoL, assessed by Venous Insufficiency Epidemiological and Economic Study-quality of life/symptoms scales (VEINES-QoL/sym). Baseline, 3 and 12 months post-intervention and yearly afterwards The VEINES-QoL/sym is a disease-specific QoL questionnaire aimed at venous disease.
Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire. Baseline, 3 and 12 months post-intervention and yearly afterwards The EQ-5D is a generic QoL questionnaire.
Change in Venous Clinical Severity Score (VCSS). 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.
Change in Villalta scale 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.
Venous claudication; number of patients with presence or absence of venous claudication pre-intervention and post-intervention during follow-up. 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).
Trial Locations
- Locations (1)
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands