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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thrombosis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Mark A de Wolf, MD; Email: m.dewolf@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6202AZ
    • Recruiting
    • Maastricht University Medical Centre
    • Contact: Mark A. de Wolf, MD; Phone Number: 0031.43.3881547; Email: m.dewolf@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Cees Wittens, MD, PhD, Maastricht University Medical Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2029

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Stent; Angioplasty; Endophlebectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: OP-VE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO