Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Recruiting
N/A
Interventional Study
Coronary Artery Disease
Coronary Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Fundación EPIC · Other
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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 adequa…
Trial Locations
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Eligibility Criteria
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…
Contacts