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Validation of a patient-specific computer model, based on already avialable images, to determine severity of groin artery stenoses.

In-vivo validation of a non-invasive, magnatic 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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27119
Enrollment
50
Registered
2017-03-09
Start date
2017-07-01
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

Peripheral arterial disease (PAD), Peripheral arterial occlussive disease (PAOD), Perifeer vaatlijden, etalage benen

Interventions

Standard of care endovascular interventions (if applicable)

Sponsors

St. Antonius Hospital Nieuwegein
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I. Age over 18; II. Symptomatic, chronic atheroslcerotic lesions of the common or externa iliac artery; III. Single or multiple borderline (50-70%) stenosis measured with ultrasound IV. Rutherford class 1-6 V. Signed informed consent

Exclusion criteria

Exclusion criteria: I. Mental disability that hinders the ability to understand and comply with the informed consent; II. Pregnancy or breast-feeding; III. Renal insufficiency (e-GFR<30 ml/min/1.73m2); IV. Patients with acute ischemic limbs or aneurismal iliac lesions; V. Patients with intimal dissections; VI. Patients with a combination of low blood pressure (RR) and high heart rate (HR) that might be at risk when inducing pharmacological hyperemia. VII. Patients with occlusive inflow (aortic) and/ or occlusions of the target iliac arteries.

Design outcomes

Primary

MeasureTime frame
validation of the MRA or CTA based personalized pre-procedural computer model, with intra-arterial pressure measurements at rest and during pharmacologically induced hyperemia as a reference

Secondary

MeasureTime frame
I. To compare the geometrical information obtained from CTA and MRA with 3D rotational angiography II To quantify the extra radiation, procedure time needed and costs made to determine the hemodynamic significance of iliac artery stenosis by means of invasive pressure measurements as compared to controlled match patient population.

Contacts

Public ContactS.G.H Heinen

St. Antonius Ziekenhuis (Vaatchirurgie)

s.heinen@antoniusziekenhuis.nl088-320 1925 (Secretariaat Heelkunde)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)