Actively Recruiting
Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach
Led by IHF GmbH - Institut für Herzinfarktforschung · Updated on 2026-03-27
310
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Some patients with coronary artery disease have severely calcified vessels. In these cases, placing a stent - a small tube that helps keep the artery open - can be very difficult. Calcium build-up in the artery wall may prevent the stent from expanding properly, increasing the risk of complications or failure of the treatment. To prepare these vessels before stenting, doctors use special techniques to modify or remove the calcium. These techniques are known as plaque modification strategies and can include devices such as atherectomy systems, scoring balloons, or intravascular lithotripsy. However, there is no clear standard as to which strategy is best. Purpose of the Study: This study compares two different approaches to treating calcified coronary arteries before stenting: * A uniform approach using only the orbital atherectomy system (Diamondback 360®, Abbott), which sands away the calcium with a rotating crown * A tailored approach, where the operator chooses from various available methods (e.g., rotational atherectomy, scoring or cutting balloons, or shockwave therapy) based on the patient's specific type of calcium The goal is to determine whether the uniform orbital atherectomy approach is not worse (non-inferior) than the individualized method when it comes to how well the stent expands inside the artery. This is a randomized, controlled clinical trial. Patients will be randomly assigned to one of the two groups. Randomization ensures fair comparison between both groups. The decision to implant a stent and to use additional techniques is at the discretion of the interventional cardiologist.
CONDITIONS
Official Title
Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chronic coronary syndrome with severely calcified lesion indicated for percutaneous coronary intervention as defined by coronary CT (Agatston Score ≥453 or Calcium Arc >270°)
- CT images must be no older than 6 months at enrollment
- Signed informed consent
- Patient suitable for bypass surgery, angioplasty, or atherectomy therapy
You will not qualify if you...
- Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours
- Cardiogenic shock
- Chronic total occlusion of the target lesion
- Glomerular filtration rate less than 30 ml/min/1.73 m2
- Contraindications listed in the device Instructions for Use at enrollment including:
- OCT imaging catheter cannot cross the lesion
- Wire or imaging catheter cannot cross the lesion
- Target lesion is within a bypass graft or stent
- Patient not suitable for bypass surgery, angioplasty, or atherectomy therapy
- Angiographic evidence of thrombus
- Only one open coronary vessel
- Angiographic evidence of flow reducing dissection at treatment site
- Known hypersensitivity to egg-, soy-, or peanut protein or to substances in the ViperSlide lubricant
- Pregnancy
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitäres Herz - und Gefäßzentrum, Unversitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
Research Team
M
Marcel Kunadt, Dr.
CONTACT
J
Jelena Weller
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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