NCT06736899

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).

Detailed description

The risk profile of patients and their comorbidities have worsened and the observed lesions undergoing treatment are increasingly complex. This has promoted the development of new technologies for plaque modification, especially in the context of calcified lesions. These predispose to suboptimal results of the intervention due to an increased risk of malapposition and underexpansion of the stents, the main variables for restenosis and/or thrombosis of the stents. Thus, compared with non-calcified lesions, the increased amount of calcium in the coronary artery leads to a higher incidence of major adverse cardiac events (MACE). Coronary bifurcation stenting remains complex and is associated with a high risk of stent thrombosis and restenosis even with contemporary techniques, and suboptimal outcomes are frequently observed due to side branch (SL) involvement that increases cardiovascular events. Our hypothesis is that the use of orbital atherectomy (OA) for coronary revascularization in the presence of calcified bifurcation lesions is feasible and safe compared to the more common technique, favoring the subsequent performance of provisional stenting (PS).

Conditions

• Coronary Artery Disease
• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Orbital Atherectomy System Treatment	Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.
DEVICE	Balloon System Treatment	Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.

Timeline

• Start date: 2025-10-23
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-17
• Last updated: 2026-04-16

Locations

6 sites across 1 country: Spain