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

NCT07105930 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-03-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung

    lead OTHER

Principal Investigators

  • Marco Ochs, PD Dr. · Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-30
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105930 on ClinicalTrials.gov