RecruitingNot ApplicableNCT07105930

Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach

A Randomized Controlled Multicentric Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach


Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Enrollment

310 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Debulging approach using the orbital atherectomy system and a procedure called Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy for people with orbital atherectomy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDebulging approach using the orbital atherectomy system

A uniform approach using only the orbital atherectomy system (Diamondback 360®), which sands away the calcium with a rotating crown

PROCEDUREDebulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy

A tailored approach, where the operator chooses from various available methods based on the patient's specific type of calcium


Locations(1)

Universitäres Herz - und Gefäßzentrum, Unversitätsklinikum Frankfurt

Frankfurt, Germany

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NCT07105930


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