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

NCT07105930 | Recruiting

• 1 other identifier: MDR-005
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Post-procedural Minimal Stent Area (MSA %) as assessed by optical coherence to-mography (OCT) imaging

  MSA will be assessed in the final OCT run performed after stent implantation withine baseline

Study Arms (2)

Debulging with the orbital atherectomy system (Diamondback 360®)

EXPERIMENTAL

Device: Debulging approach using the orbital atherectomy system

Debulging with various available methods

ACTIVE COMPARATOR

Procedure: Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy

Interventions

Debulging approach using the orbital atherectomy system DEVICE

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

Debulging with the orbital atherectomy system (Diamondback 360®)

Debulging using rotational atherectomy, scoring or cutting balloons, or shockwave therapy PROCEDURE

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

Debulging with various available methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 Years
• Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc \>270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment.
• Signed informed consent
• The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy

You may not qualify if:

• Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours
• Cardiogenic shock
• Chronic total occlusion of the target lesion
• Glomerular filtration rate \< 30 ml/min/1.73 m2
• Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device:
• The OCT (optical coherence tomography) imaging catheter cannot cross
• The wire or imaging catheter cannot cross
• The target lesion is within a bypass graft or stent
• The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy.
• The patient has angiographic evidence of thrombus
• The patient has only one open coronary vessel
• The patient has angiographic evidence of flow reducing dissection at the treatment site
• The patient has a known hypersensitivity to egg-, soy-, or peanut protein or to any of the active substances or excipients of the ViperSlide™ lubricant
• Pregnancy (assessed by clinical routine testing)
• Participation in another interventional clinical trial

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead

Study Sites (1)

Universitäres Herz - und Gefäßzentrum, Unversitätsklinikum Frankfurt

Frankfurt, Germany

RECRUITING

Study Officials

• Marco Ochs, PD Dr.

  Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcel Kunadt, Dr.

CONTACT

+49 621 59577 223; orfita@ihf.de

Jelena Weller

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 6, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

DE (1)