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OCT below-the-knee

The impact of optical coherence tomography on the endovascular treatment of below-the-knee arteries’ - OCT below-the-knee

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58134
Enrollment
20
Registered
2025-05-27
Start date
2025-12-11
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Peripheral arterial disease

Interventions

Intravascular optical coherence tomography

Sponsors

Rijnstate
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged = 18 yearsWritten informed consentScheduled endovascular treatment of infrapopliteal arteries (tibioperoneal trunk, anterior or posterior tibial artery, fibular artery)

Exclusion criteria

Exclusion criteria: Severely impaired renal function (eGFR < 30 ml/min)Cardiac insufficiency (NYHA 3-4)Pregnant women or women of child-bearing age not on active birth controlLegally incapable to provide informed consent

Design outcomes

Primary

MeasureTime frame
The percentage of procedures in which OCT evaluation of endovascular treatment would lead to additional treatment compared to the DSA-based treatment evaluation.The percentage of vessels in which OCT evaluation of endovascular treatment would lead to additional treatment compared to the DSA-based treatment evaluation.The correlation between adverse imaging findings on completion OCT and restenosis on 3-month, 6-month and 12-month follow-up imaging.

Secondary

MeasureTime frame
The percentage of procedures in which OCT changed the DSA-based treatment planning before the initial endovascular treatmentThe percentage of vessels in which OCT changed the DSA-based treatment planning before the initial endovascular treatment

Countries

Netherlands

Contacts

Public ContactD.J. Rademakers

Rijnstate

researchvascularsurgery@rijnstate.nl0880057282

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026