Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02650453
Other study ID # OP-VE-01
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02567903 - Tourniquet Study: A Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System N/A
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Completed NCT02065388 - Pharmacogenetic Dosing of Warfarin Phase 3
Completed NCT00839657 - Clarification of Optimal Anticoagulation Through Genetics Phase 3
Terminated NCT00872079 - Personalized Warfarin Dosing by Genomics and Computational Intelligence N/A
Terminated NCT00521885 - Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients N/A
Completed NCT00346424 - Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters Phase 3
Completed NCT02892565 - Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System) N/A
Active, not recruiting NCT04349189 - Venous Thrombosis Biomarkers in Sickle Cell Disease and Sickle Cell Trait
Recruiting NCT02238444 - Warfarin Prevents Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy Phase 4
Recruiting NCT02597218 - Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.
Completed NCT00986154 - Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study). Phase 3
Completed NCT00246025 - A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery. Phase 2
Completed NCT00097357 - BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery Phase 2/Phase 3
Completed NCT04645550 - Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy(ESAWAAPT) Phase 4
Recruiting NCT02264743 - Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy Phase 4
Completed NCT01482273 - Ultrasound-enhanced Thrombolysis Versus Standard Catheter Directed Thrombolysis for Ilio-femoral Deep Vein Thrombosis N/A
Recruiting NCT01252420 - Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis Phase 4
Completed NCT01145859 - Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects Phase 1
Completed NCT00790335 - Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis Phase 3