In-vivo validation of non-invasive, magnetic resonance or computed tomography based patient-specific pressure model to determine the severity of common and external iliac artery obstructions, and the need for revascularization non-invasively.

In-vivo validation of non-invasive, magnetic resonance or computed tomography based patient-specific pressure model to determine the severity of common and external iliac artery obstructions, and the need for revascularization non-invasively. - DETECT-PAD study 2.0

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49149

Enrollment

Registered

2020-03-03

Start date

2017-08-24

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Intermittent claudication peripheral arterial disease

Interventions

Diagnoses optimization

Non-invasive modelling

Patient-specific modelling

Peripheral arterial disease

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age over 18; Symptomatic, chronic atheroslerotic lesions of the common or external iliac artery; One or multiple borderline (50-70%) stenosis measured with ultrasound; Rutherford class 1-6; Signed informed consent.

Exclusion criteria

Exclusion criteria: Inability to undergo all measurements; Mental disability that hinders the ability to understand and comply with the informed consent; Pregnancy or breast-feeding; Renal insufficiency (e-GFR

Design outcomes

Primary

Measure	Time frame
Not applicable. In vivo measured data is compared with data predicted by a mathematical model.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)