Orbital atherectomy alone versus a tailored calcium-removal approach before coronary stenting.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional non-inferiority comparison enrolls adults with CT-confirmed severely calcified coronary lesions and randomizes them to a uniform orbital atherectomy approach (Diamondback 360®) or a calcium-tailored debulking strategy chosen by the operator. The tailored arm may include rotational atherectomy, scoring or cutting balloons, or intravascular lithotripsy (shockwave) before stent placement. Eligibility requires a recent CT (≤6 months) showing high lesion calcium burden by Agatston score or calcium arc. Key outcomes focus on procedural success, stent expansion, and complications related to vessel preparation and stenting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Universitäres Herz - und Gefäßzentrum, Unversitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting

Study contacts

• Principal investigator: Marco Ochs, PD Dr. — Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
• Study coordinator: Marcel Kunadt, Dr.
• Email: orfita@ihf.de
• Phone: +49 621 59577 223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.