ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.
Rutherford classification category ≥4;
Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;
Calcification of target lesions must be visible on fluoroscopy or CT-angiography;
Patients competent and willing to provide informed consent.
Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);
Inadequate inflow (>30% stenosis) following optimization;
Insufficient direct outflow (less than 1 run-off vessel);
Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;
Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions treated with OA using the Stealth 360 Peripheral OA System for vessel preparation prior to any adjunctive endovascular procedure.
Cohort
Prospective
Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
DeviceThe Stealth 360™ Peripheral Orbital Atherectomy System uses a diamond-coated, eccentrically mounted crown with bi-directional capabilities that treat a wide range of vessels, enabling single device treatment of multiple lesions and vessel sizes.
Number of lesions with ≤30% residual stenosis after completion of full planned procedure
Defined as residual stenosis ≤30%, immediately after completion of full planned procedure (OA + any planned adjunctive intervention(s)).
Number of lesions with ≤30% residual stenosis after any unplanned endovascular intervention(s)
Defined as residual stenosis ≤30% immediately after completion of additional unplanned endovascular intervention(s) (any endovascular procedure that was not part of the primary procedure plan).
Need for unplanned bailout stenting
Defined as any stent placement that was not part of the primary procedure plan.
Number of participants free from Clinically-Driven Target Lesion Revascularization (CD-TLR)
Defined as freedom from any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.
CD-TLR-free survival
Defined as time between first OA procedure and any endovascular re-intervention to the target lesion (± 10 mm) or surgical bypass performed because of restenosis or occlusion of the target lesion.
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