NCT07105930

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orbital Atherectomy

Interventions

Type	Name	Description
DEVICE	Debulging 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
PROCEDURE	Debulging 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

Timeline

• Start date: 2025-10-30
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-08-06
• Last updated: 2026-03-27

Locations

1 site across 1 country: Germany