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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02867501
Other study ID # 2016-00375
Secondary ID
Status Completed
Phase N/A
First received August 11, 2016
Last updated March 31, 2017
Start date May 2016
Est. completion date March 28, 2017

Study information

Verified date March 2017
Source Kantonsspital Baselland Bruderholz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to assess if venous distension in patients with aneurysmatic arteriopathy is higher compared to patients with peripheral arterial occlusive disease (PAOD) and in controls.


Description:

Patients with aortic aneurysm and patients with PAOD and Controls will be investigated in the following manner: Duplexsonography with assessment of the arterial diameters in the aorta and leg arteries. Duplexsonography with assessment of venous reflux in proximal and deep veins of both legs Duplexsonography testing of venous distension in the common femoral vein, the great saphenous vein and the femoral vein.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date March 28, 2017
Est. primary completion date March 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with dilatative arteriopathy (DA) the aortic diameter must be > 3 cm or the popliteal artery diameter > 1.5 cm

- Patients with arterial occlusive disease (PAOD) defined with an Ankle brachial index (ABI) < 0.9 and positive criteria in the Edinburgh questionnaire

- Patients able to give informed consent

- Control group of age matched persons without PAOD (ABI > 0.9) and without DA

Exclusion Criteria:

- Impossibility to stand

- Diabetes

- No given informed consent

- Persons and patients < 18 years old

- Acute deep venous thrombosis

- History of deep venous thrombosis

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kantonsspital Baselland Bruderholz

References & Publications (2)

Jeanneret C, Baldi T, Hailemariam S, Koella C, Gewaltig J, Biedermann BC. Selective loss of extracellular matrix proteins is linked to biophysical properties of varicose veins assessed by ultrasonography. Br J Surg. 2007 Apr;94(4):449-56. — View Citation

Jeanneret C, Jäger KA, Zaugg CE, Hoffmann U. Venous reflux and venous distensibility in varicose and healthy veins. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):236-42. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Venous distension of > 27% in patients with aneurysmatic arterial disease one year
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