Athérectomie orbitale pour la préparation de la lésion chez les patients atteints d'ischémie chronique menaçant le membre (ORACLE)

Eligible patients are those who will undergo OA prior to any adjunctive endovascular procedure

The 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.

• Athérectomie orbitaire
• Système d'athérectomie orbitale

Defined as residual stenosis ≤30%, immediately after completion of full planned procedure (OA + any planned adjunctive 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).

Defined as any stent placement that was not part of the primary procedure plan.

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.

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.

The Rutherford classification is a clinical scale used to categorize the severity of peripheral arterial disease: Category 0 = asymptomatic; Category 1 = mild claudication; Category 2 = moderate claudication; Category 3 = severe claudication; Category 4 = ischemic rest pain; Category 5 = minor tissue loss; Category 6 = severe tissue loss.

Defined as healing status of the dominant ischemic wound of the target limb (complete, partial, unchanged, worsening).

Defined as absence of any amputation of the target limb (above ankle).

Defined as time between first OA procedure and above-ankle amputation of the target limb.

Defined as the time between the first OA procedure and death of any cause.

Measured by Vascular Quality of Life Questionnaire - 6 items (VascuQol-6), which is a short patient-reported outcome measure (PROM), used to assess health-related quality of life in people with PAD. It consists of 6 questions, each scored from 1 to 7, with 1 as the worst possible quality of life and 7 as the best possible quality of life. Higher overall scores reflect better quality of life for patients with PAD.

Grading according to the classification system of the Cardiovascular and Interventional Radiological Society of Europe.

The ankle-brachial index (ABI) is a non-invasive measure calculated as the ratio of systolic blood pressure at the ankle to systolic blood pressure at the arm. ABI categories commonly used to classify peripheral arterial disease are: >1.40 = non-compressible arteries; 1.00-1.40 = normal; 0.91-0.99 = borderline; 0.41-0.90 = mild to moderate peripheral arterial disease; <0.40 = severe peripheral arterial disease.

The toe pressure test measures distal limb perfusion by recording systolic pressure at the toe. In CLTI patients, toe pressure ≤30 mmHg is commonly used to indicate severe ischemia, while values >30 mmHg suggest better perfusion.

The WIfI classification is a staging system used to assess CLTI based on wound extent, ischemia severity, and foot infection. Each component is graded from 0 (none) to 3 (severe). Lower WIfI scores indicate a lower risk of limb loss and a lesser urgency for revascularization, whereas higher scores indicate greater disease severity, higher amputation risk, and greater potential benefit from revascularization.