Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication (TIRED)

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Venous Insufficiency

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mohammad E Barbati, MD; Phone Number: +492418035292; Email: mbarbati@ukaachen.de
• Study Contact Backup: Name: Gaby Heuer, SN; Phone Number: +492418035881; Email: gheuer@ukaachen.de

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Recruiting
      • Universitätsklinikum Aachen
      • Contact: Universitätsklinikum Aachen; Phone Number: 02418035881; Email: gheuer@ukaachen.de
      • Sub-Investigator: Mohammad E Barbati, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with obstruction in the common femoral vein, external iliac vein, common iliac vein, or inferior vena cava

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Houman Jalaie, MD, Universitätsklinikum Aachen Klinik für Gefäßchirurgie

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: Universitätsklinikum Aachen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No