Randomized trial, the application of non penetrating vascular clips of the anastomosis of the femoral artery.

Randomized trial, the application of non penetrating vascular clips of the anastomosis of the femoral artery. - non penetrating vascular clips and vascular disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33216

Enrollment

Registered

2010-03-03

Start date

2010-05-28

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

surgery vascular anastomosis

Interventions

The anastomosis or patch angioplasty we will examine is at the level of the common femoral artery. The suture will be vascufil and the VSC clip applier system Auto Suture. The reason why we will ex

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Arterial occlusive disease, Fontaine 2b or severe, which needs treatment with a venous peripheral bypass. - Arterial occlusive disease, Fontaine 2b or severe, which needs treatment with a desobstrcution of the femoral artery.

Exclusion criteria

Exclusion criteria: - follow up is possible over more than one year - pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Measurement of the ankle/arm index at day 1, week 6, week 12 and after 1 year. Measurement of the quality of the bypass of patch angioplasty at the level of the common femoral artery by means of color duplex ultrasonography at week 6, week 12, week 26 and 1 year after surgery.	—

Secondary

Measure	Time frame
difficulties during the operation, operation time	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)