Chronic Venous InsufficiencyTIREDNCT05662761
Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication
An observational study of Chronic Venous Insufficiency, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Venous Insufficiency
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2022to 30 Dec 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with obstruction in the common femoral vein, external iliac vein, common iliac vein, or inferior vena cava
Who may be able to join
- Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior
- Age: 18-80 years old
- Signed informed consent form
- Persons who are legally competent and mentally capable, to follow the instructions of the staff
Who cannot join
- Patients under 18 years of age.
- Patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing.
- Persons acting by administrative or judicial order are housed in a facility
- Patients who abuse drugs
- Peripheral arterial disease stage IIb, III and IV -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
Universitätsklinikum Aachen, 02418035881, gheuer@ukaachen.de
Mohammad E Barbati, MD
About this study
Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication
Read the detailed description
The postthrombotic syndrome (PTS) occurs in about 20-50% of patients after a deep Venous thrombosis and significantly affects the quality of life of patients. With the patency rates of 73-100% are achieved with endovascular procedures. At 58% of patient ulcer healing was achieved. Neglen et al. could a significant demonstrate an improvement in quality of life. Aim of the study: To show the influence of the increased inflow to venous Objectively review recanalization for patient symptoms and walking performance. Therefore, before and after venous interventions, to assess walking performance and pain-free Measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.
- Conditions
- Chronic Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic chronic obstruction | patients with symptomatic chronic obstruction of the femoroiliac and caval vein segments (VFC, VIE, VIC, VCI) treated with stent angioplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain -free walking distance
pain-free walking distance after venous recanalization and stent implantation
Measured: 2022-2025
Secondary outcomes (2)
Stent openness rate
Stent openness rate
Measured: 2022-2025
2
Quality of life of the patients after venous recanalization and stent-lmpl.antption
Measured: 2022-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start31 Mar 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Houman Jalaie, RWTH Aachen University
- Investigators
- Houman Jalaie, MD, Principal investigator, Universitätsklinikum Aachen Klinik für Gefäßchirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662761
- Sponsor's protocol ID
- Universitätsklinikum Aachen
- Acronym
- TIRED
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication
- ClinicalTrials.gov ID
- NCT05662761
- Acronym / sponsor ID
- TIRED / Universitätsklinikum Aachen
- Conditions
- Chronic Venous Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Dec 2022 (actual)
- 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.
Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication
Detailed description
The postthrombotic syndrome (PTS) occurs in about 20-50% of patients after a deep Venous thrombosis and significantly affects the quality of life of patients. With the patency rates of 73-100% are achieved with endovascular procedures. At 58% of patient ulcer healing was achieved. Neglen et al. could a significant demonstrate an improvement in quality of life. Aim of the study: To show the influence of the increased inflow to venous Objectively review recanalization for patient symptoms and walking performance. Therefore, before and after venous interventions, to assess walking performance and pain-free Measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic chronic obstruction | – | –patients with symptomatic chronic obstruction of the femoroiliac and caval vein segments (VFC, VIE, VIC, VCI) treated with stent angioplasty. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obstruction in the common femoral vein, external iliac vein, common iliac vein, or inferior vena cava
Key inclusion criteria (4 listed)
- Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior
- Age: 18-80 years old
- Signed informed consent form
- Persons who are legally competent and mentally capable, to follow the instructions of the staff
Key exclusion criteria (5 listed)
- Patients under 18 years of age.
- Patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing.
- Persons acting by administrative or judicial order are housed in a facility
- Patients who abuse drugs
- Peripheral arterial disease stage IIb, III and IV -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pain -free walking distance
Time frame: 2022-2025
pain-free walking distance after venous recanalization and stent implantation
2 secondary outcomes
Stent openness rate
Time frame: 2022-2025
2
Time frame: 2022-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- 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. This study is not recruiting at the moment.
Houman Jalaie, MD principal investigator
Universitätsklinikum Aachen Klinik für Gefäßchirurgie
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 Chronic Venous Insufficiency, run by RWTH Aachen University at 1 site in Germany.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Dec 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad E Barbati, MD (+492418035292, mbarbati@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain -free walking distance (time frame: 2022-2025). 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 22 Dec 2022.