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Compares treatment options for Coronary Artery Disease
Official title Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
ClinicalTrials.gov ID: NCT06736899
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients agree to participate in the study, by signing the Informed Consent.
You likely can't join if
- 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.
See the full eligibility 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...
- Patients agree to participate in the study, by signing the Informed Consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Spain
- Barcelona, Spain
- Córdoba, Spain
- Fuencarral-El Pardo, Spain
- Lugo, Spain
- Madrid, Spain
- Salamanca, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alicante, Spain; Barcelona, Spain; Córdoba, Spain; Fuencarral-El Pardo, Spain; Lugo, Spain; Madrid, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.