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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05662761

Acronym

TIRED

Enrollment

100

Registered

2022-12-22

Start date

2022-03-31

Completion date

2025-12-30

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Insufficiency

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
pain -free walking distance	2022-2025	pain-free walking distance after venous recanalization and stent implantation

Secondary

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

Countries

Germany

Contacts

Primary ContactMohammad E Barbati, MD

mbarbati@ukaachen.de+492418035292

Backup ContactGaby Heuer, SN

gheuer@ukaachen.de+492418035881

Outcome results