ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia

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).

Time frame: Immediately after procedure completion

Need for unplanned bailout stenting

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

Time frame: Immediately after procedure completion

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.

Time frame: 12 and 24 months

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.

Time frame: Until the end of the follow-up period of 2 years

Clinical response using Rutherford classification categories

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.

Time frame: 12 and 24 months

Wound status

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

Time frame: 12 and 24 months

Freedom from amputation of the target limb

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

Time frame: 12 and 24 months

Amputation-free survival

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

Time frame: Until the end of the follow-up period of 2 years

Overall survival

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

Time frame: Until the end of the follow-up period of 2 years

Patient-reported health-related quality-of-life

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.

Time frame: Baseline, 6, 12 and 24 months post treatment

Frequency and severity of procedural complications and other adverse events

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

Time frame: Within 30 days after the OA procedure

Clinical response using ankle-brachial index (ABI)

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.

Time frame: 12 and 24 months

Clinical response using toe pressure

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.

Time frame: 12 and 24 months

Clinical response using WIfi (wound, ischemia and foot infection) score

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.

Time frame: 12 and 24 months