Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Coronary Disease

• Registration Number: NCT06736899
• Lead Sponsor: Fundación EPIC

Brief 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).

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-17
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06
• Study Start: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
EFFICACY: Angiographic criteria success	At the end of PCI (Percutaneous Coronary Intervention)	Percentage of Main vessel and side branch (≥2 mm) patency (final stenosis \<20%) without the presence of: residual lesion \>70% and TIMI flow \< 3 and residual ≥ type C disection
EFFICACY: OCT criteria: Stent expansion	At the end of PCI	Percentage of MLA / mean reference luminal area (mean proximal and distal reference luminal)

Secondary Outcome Measures

Name	Time	Method
SAFETY:Major adverse cardiac events (MACE)	At the end of PCI	Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA) in mm2	At the end of PCI	Cut-off point \>5 mm2
EFFICACY: Other variables related to stent expansion. Minimal Lumen Area (MLA)	At the end of PCI	Percentage of Cut-off point \>90 mm2
EFFICACY: Other variables related to stent expansion. Mean stent expansion	At the end of PCI	Percentage of mean stent area (sum of stent area/analyzed stent length)/mean reference lumen area (cut-off point\>80%)
EFFICACY: Other variables related to stent expansion. Stent expansion using linear model	At the end of PCI	Percentage of stent volume/adaptative reference lumen volume. (cut-off point\>65%)