Ongoing Registry of Deep Venous Reconstructions

Venous Thrombosis Clinical Trial

Official title:

Ongoing Registry of Deep Venous Reconstructions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02650453
• Other study ID #: OP-VE-01
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2015
• Last updated: January 7, 2016
• Start date: September 2009
• Est. completion date: September 2029

Study information

• Verified date: December 2015
• Source: Maastricht University Medical Center
• Contact: Mark A de Wolf, MD
• Email: m.dewolf[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2029
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards	No
Secondary	Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.	The SF-36 is a generic QoL questionnaire.	Baseline, 12 and 52 weeks post-intervention, and yearly thereafter.	No
Secondary	Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire.	The EQ-5D is a generic QoL questionnaire.	Baseline, 3 and 12 months post-intervention and yearly afterwards	No
Secondary	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.	Baseline, 3 and 12 months post-intervention and yearly afterwards	No
Secondary	Change in Venous Clinical Severity Score (VCSS).	The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.	Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards	No
Secondary	Change in Villalta scale	The Villalta scale is a validated scoring system for assessing signs, symptoms and complaints of the post-thrombotic syndrome.	Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards	No
Secondary	Venous claudication; number of patients with presence or absence of venous claudication pre-intervention and post-intervention during follow-up.	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).	Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards	No