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

Recruiting

• Conditions: Chronic Venous Insufficiency

• Registration Number: NCT05662761
• Lead Sponsor: RWTH Aachen University

Brief Summary

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 Timeline

• Study Start: 2022-03-31
• Status Verified: 2022-12
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-15
• Last Update Submitted: 2022-12-15
• Study First Posted: 2022-12-22
• Last Update Posted: 2022-12-22
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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 -

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain -free walking distance	2022-2025	pain-free walking distance after venous recanalization and stent implantation

Secondary Outcome Measures

Name	Time	Method
2	2022-2025	Quality of life of the patients after venous recanalization and stent-lmpl.antption
Stent openness rate	2022-2025	Stent openness rate

Trial Locations

Locations (1)

Universitätsklinikum Aachen; 🇩🇪 Aachen, NRW, Germany