Optical Coherence Tomography (OCT) guided Percutaneous Transluminal Angiography (PTA) in lesions below the knee: a proof of concept study

Optical Coherence Tomography (OCT) guided Percutaneous Transluminal Angiography (PTA) in lesions below the knee: a proof of concept study - OCT-guided PTA concept

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51664

Enrollment

Registered

2022-11-24

Start date

2023-04-12

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

'peripheral arterial disease' en 'intermittent claudication'

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients of any race or sex, and any age above 18 years, who electively undergo a single-lesion PTA of the anterior or posterior tibial artery - The lesion is no longer than 3 cm - Critical limb ischemia defined as Fontaine class 3 or 4 - Patients provide informed consent - Kidney function with eGFR > 30 ml/min, allowing contrast iodine to be used unless patient is dependent on dialysis without residual diuresis

Exclusion criteria

Exclusion criteria: - Acute limb ischemia - Revascularization involving the same limb within 30 days prior to the index procedure - Known allergy to iodine contrast - Previous implanted stent at the index site - Previous major amputation in the same limb as the index site - Pregnant patients

Design outcomes

Primary

Measure	Time frame
The main question to be answered is: Is OCT safe to use in PTA procedures in patients with critical limb ischemia in below the knee arteries in the Zuyderland Medical Center, and what is the effect of OCT on intraoperative decision-making?	—

Secondary

Measure	Time frame
For the secondary objectives, the following questions will be answered. - What is the difference in millimeters between the measured diameter of the vessel using OCT and the estimation of the surgeon based on DSA? - In what percentage of cases would intraoperative decision making have been altered knowing the OCT measurement in terms of balloon and stent sizing, stent placing and the surgical endpoint?	—

Measure

Time frame

For the secondary objectives, the following questions will be answered. - What is the difference in millimeters between the measured diameter of the vessel using OCT and the estimation of the surgeon based on DSA? - In what percentage of cases would intraoperative decision making have been altered knowing the OCT measurement in terms of balloon and stent sizing, stent placing and the surgical endpoint?

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Countries

Netherlands

Outcome results