Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
Patients in cardiogenic shock.
Patients with Thrombotic lesions.
Patients with Vascular graft disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Orbital Atherectomy System Treatment
DevicePercutaneous 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.
Balloon System Treatment
DevicePercutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Balloon Angioplasty (BA)Active comparator 1 intervention
Group B: Orbital Atherectomy (OA)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
EFFICACY: Angiographic criteria success
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
Time frame
At the end of PCI (Percutaneous Coronary Intervention)2
EFFICACY: OCT criteria: Stent expansion
Percentage of MLA / mean reference luminal area (mean proximal and distal reference luminal)
Time frame
At the end of PCISecondary outcomes
1
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Time frame
12 months2
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Time frame
6 months3
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Time frame
30 days4
SAFETY:Major adverse cardiac events (MACE)
Rate of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and non-target lesion target vessel revascularization (TVR non-TLR), thrombosis and stroke
Time frame
At the end of PCISponsors and contacts
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Source ClinicalTrials.gov