Fractional Flow Reserve in Critical Limb Ischemia Patients

Fractional Flow Reserve in Critical Limb Ischemia Patients - FFR-guided PTA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53557

Enrollment

Registered

2023-02-07

Start date

2023-05-07

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: In order to be eligible to participate in this study, a subject must meet all the following 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

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Acute limb ischemia - Complete atrioventricular node block - 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 FFR 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 FFR on intraoperative decision-making?	—

Secondary

Measure	Time frame
Secondary to proving the safety and feasibility of FFR in BTK lesions, this study aims to provide information on the effect of FFR on perioperative decision making regarding the surgical endpoint, compared to the decisions made based on conventional DSA. The secondary objective is to find out in what percentage of cases intraoperative decision making would have been altered based on the information provided by FFR in terms of balloon and stent sizing, stent placing and the surgical endpoint. Since FFR is able to provide information on the quality of microvasculature in the tissue supplied by the artery of interest, FFR might be able to predict the success of the PTA in terms of peripheral vascular disease related symptom reduction and limb healthiness. Thus, a secondary objective is to investigate whether the significance of the stenosis based on the FFR measurement corresponds to the outcome after 6 weeks of follow-up, by comparing the difference in Fontaine scale before and 6 weeks after PTA to the prediction made by FFR.	—

Measure

Time frame

Secondary to proving the safety and feasibility of FFR in BTK lesions, this study aims to provide information on the effect of FFR on perioperative decision making regarding the surgical endpoint, compared to the decisions made based on conventional DSA. The secondary objective is to find out in what percentage of cases intraoperative decision making would have been altered based on the information provided by FFR in terms of balloon and stent sizing, stent placing and the surgical endpoint. Since FFR is able to provide information on the quality of microvasculature in the tissue supplied by the artery of interest, FFR might be able to predict the success of the PTA in terms of peripheral vascular disease related symptom reduction and limb healthiness. Thus, a secondary objective is to investigate whether the significance of the stenosis based on the FFR measurement corresponds to the outcome after 6 weeks of follow-up, by comparing the difference in Fontaine scale before and 6 weeks after PTA to the prediction made by FFR.

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Countries

Netherlands

Outcome results