ORACLE

ORbital Atherectomy for lesion preparation in patients with Critical Limb-threatening ischEmia

Status: in design

Study summary | Objective and outcome measures | Steering Committee

Study summary

ORACLE is a Europe-wide, prospective, observational cohort study designed to evaluate the effectiveness of orbital atherectomy (OA) in 250 participants with critical limb-threatening ischemia (CLTI). The study aims to generate real-world data on the use of this vessel preparation technique for the treatment of calcified femoropopliteal or infrapopliteal lesions.

OA is a minimally invasive procedure that removes calcium buildup in arteries,  improving luminal gain, and preparing the vessel for balloon angioplasty or other adjunct therapies. By promoting the success of subsequent endovascular interventions, OA may significantly contribute to increasing blood flow in the vessel, reducing the likelihood of restenosis, lowering the need for revascularization and improving clinical outcomes like wound healing and freedom from amputation.

ORACLE plans to recruit a maximum of 250 patients during the 3-year enrolment phase with an anticipated start in April 2026. Follow-up will continue for 2 years beyond the enrolment phase.

The project is funded by Abbott via their Investigator Sponsored Studies Program.

Objective and outcome measures

The primary objective of ORACLE is to assess the immediate clinical effectiveness of OA combined with angioplasty/stenting in restoring adequate lumen diameter, defined as residual stenosis ≤30%.

As secondary objectives, ORACLE intends to evaluate the effectiveness of OA combined with angioplasty/stenting in i) preventing the need for bailout stenting, ii) restoring long-term patency of the vessel and delaying the need for revascularization, iii) improving clinical symptoms and health-related quality of life, iv) promoting wound healing and preventing amputation, and v) prolonging survival.

Secondary long-term effectiveness endpoints will be assessed at 12 and 24 months and include freedom from clinically driven target lesion revascularization (CD-TLR), primary- assisted primary- and secondary patency, wound healing and freedom from amputation. CD-TLR-free survival, amputation-free survival and overall survival will also be reported.

Steering Committee