Venous ThrombosisNCT02650453
Ongoing Registry of Deep Venous Reconstructions
An observational study of Venous Thrombosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Deep venous reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava
Who cannot join
- Intolerance to anticoagulant medication
- A life expectancy <1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mark A de Wolf, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre
Maastricht, 6202AZ
Mark A. de Wolf, MD, 0031.43.3881547, m.dewolf@maastrichtuniversity.nl
About this study
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.
Read the 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.
- Conditions
- Venous Thrombosis
- Being tested
- Deep venous reconstruction
- Keywords
- Stent, Angioplasty, Endophlebectomy
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep venous reconstructionProcedure or surgery
PTA \& stenting with/without endophlebectomy and/or arteriovenous fistula creation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Secondary outcomes (6)
Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.
The SF-36 is a generic QoL questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startSep 2009
- Primary completionSep 2019 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Wittens, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650453
- Sponsor's protocol ID
- OP-VE-01
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ongoing Registry of Deep Venous Reconstructions
- ClinicalTrials.gov ID
- NCT02650453
- Acronym / sponsor ID
- OP-VE-01
- Conditions
- Venous Thrombosis
- Keywords
- Stent, Angioplasty, Endophlebectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava
Key exclusion criteria (2 listed)
- Intolerance to anticoagulant medication
- A life expectancy <1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep venous reconstructionPTA \& stenting with/without endophlebectomy and/or arteriovenous fistula creation | Procedure or surgery | – |
Primary outcome
Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals.
Time frame: 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.
6 secondary outcomes
Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey.
Time frame: Baseline, 12 and 52 weeks post-intervention, and yearly thereafter.
Change in QoL, assessed by EuroQol 5 Dimensions (EQ-5D) questionnaire.
Time frame: 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).
Time frame: Baseline, 3 and 12 months post-intervention and yearly afterwards
Change in Venous Clinical Severity Score (VCSS).
Time frame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Change in Villalta scale
Time frame: 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.
Time frame: Baseline, 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark A de Wolf, MD contact
Cees Wittens, MD, PhD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark A de Wolf, MD (m.dewolf@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patency (primary, assisted primary and secondary) of the treated vein tracts assessed by duplex ultrasonography at regular time intervals. (time frame: 2, 6, 12, 23, 52 weeks post-intervention and yearly afterwards). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.