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

NCT ID: NCT05662761

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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

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Chronic Venous Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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symptomatic chronic obstruction

patients with symptomatic chronic obstruction of the femoroiliac and caval vein segments (VFC, VIE, VIC, VCI) treated with stent angioplasty.

No interventions assigned to this group

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Houman Jalaie

Deputy Head of the Department of Vascular & Endovascular Surgery of the University Hospital of AachenPD Dr. med Houman Jalaie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Houman Jalaie, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Aachen Klinik für Gefäßchirurgie

Locations

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Universitätsklinikum Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Mohammad E Barbati, MD

Role: CONTACT

Phone: +492418035292

Email: [email protected]

Gaby Heuer, SN

Role: CONTACT

Phone: +492418035881

Email: [email protected]

Facility Contacts

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Universitätsklinikum Aachen

Role: primary

Other Identifiers

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Universitätsklinikum Aachen

Identifier Type: -

Identifier Source: org_study_id