Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions (OraBil)

Fundación EPIC

Status

Enrolling

Conditions

Coronary Artery Disease

Coronary Disease

Treatments

Device: Orbital Atherectomy System Treatment

Device: Balloon System Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06736899

EPIC44-OraBil

Details and patient eligibility

About

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).

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 18 years of age and
Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and
Patients agree to participate in the study, by signing the Informed Consent.

Exclusion criteria

Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
Patients with contraindication for the use of Orbital Atherectomy:
- Patients in cardiogenic shock.
- Patients with Thrombotic lesions.
- Patients with Vascular graft disease.
- Patients with remain vessel disease.
- Patients with severe left ventricular dysfunction.
- Patients allergic to the components of the washing serum (glide).
Patients with life expectancy less than one year.