NCT06736899Recruiting
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 11 Dec 2024
- Start date
- 23 Oct 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT06736899
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 23 Oct 2025 to the primary completion date, 31 Dec 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.
Lab values
- 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).
Other
- Patients with life expectancy less than one year.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| H. G.U. de ALICANTE DR. BALMIS Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| H. de la Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Fuencarral-El Pardo | Spain | Recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hospital Universitario La Luz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitari de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.