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Balloon test for iliac vein compression

Balloon test for iliac vein compression - Balloon test study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42561
Enrollment
23
Registered
2015-10-14
Start date
2016-01-20
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

iliac vein compression syndrome may-thurner syndrome

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18 - 45 years

Exclusion criteria

Exclusion criteria: - Disease affecting the circulatory system, such as cardiac disease, varicosities or peripheral arterial disease, on the basis of anamnesis. - History of bleeding or clotting disorders - Complaints of the abdomen or leg consistent with iliac vein compression syndrome or pelvic congestion syndrome - CEAP classification of C2 or higher (C0: no venous signs, C1: venectasia, C2: varicose veins, C3: edema, C4: skin changes, C5 healed ulcer, C6: active ulcer) - History of deep venous thrombosis or pulmonary embolism. - History of surgery of the abdomen, groin or lower limb - Pregnancy - Allergy to contrast or lidocaine - Active malignancy

Design outcomes

Primary

MeasureTime frame
The main endpoint of this study is the presence of collaterals (passing the midline) after balloon occlusion of the left common iliac vein, which is scored as present or not. (also location and amount if present and expressed as a prevalence percentage)

Secondary

MeasureTime frame
Demographic characteristics

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)