Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication

Chronic Venous Insufficiency Clinical Trial

— TIRED  

Official title:

Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662761
• Other study ID #: Universitätsklinikum Aachen
• Status: Recruiting
• Start date: March 31, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2022
• Source: RWTH Aachen University
• Contact: Mohammad E Barbati, MD
• Phone: +492418035292
• Email: mbarbati[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior

2. Age: 18-80 years old

3. Signed informed consent form

4. Persons who are legally competent and mentally capable, to follow the instructions of the staff

Exclusion Criteria:

1. Patients under 18 years of age.

2. 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.

3. Persons acting by administrative or judicial order are housed in a facility

4. Patients who abuse drugs

5. Peripheral arterial disease stage IIb, III and IV -

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain -free walking distance	pain-free walking distance after venous recanalization and stent implantation	2022-2025
Secondary	Stent openness rate	Stent openness rate	2022-2025
Secondary	2	Quality of life of the patients after venous recanalization and stent-lmpl.antption	2022-2025