Orbital atherectomy alone versus a tailored calcium-removal approach before coronary stenting.
A Randomized Controlled Multicentric Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach
NA · IHF GmbH - Institut für Herzinfarktforschung · NCT07105930
This compares whether using orbital atherectomy alone works as well as choosing different calcium-removal methods for people with severely calcified coronary arteries who need a stent.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHF GmbH - Institut für Herzinfarktforschung (other) |
| Locations | 1 site (Frankfurt) |
| Trial ID | NCT07105930 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with chronic coronary syndrome and a CT-confirmed severely calcified target lesion (Agatston score ≥453 or calcium arc >270°), who are candidates for percutaneous coronary intervention and consent to participate.
Not a fit: Patients with recent STEMI (within 48 hours), cardiogenic shock, chronic total occlusion of the target lesion, severe renal impairment (GFR <30 ml/min/1.73 m2), or other device contraindications — or without a CT ≤6 months old — are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, an orbital-only approach could simplify procedures, reduce device changes and procedure time, and achieve similar stent results with fewer complications.
How similar studies have performed: Previous studies support the use of atherectomy and intravascular lithotripsy for calcified lesions, but direct head-to-head non-inferiority comparisons of orbital-only versus operator-tailored strategies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Frankfurt
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Orbital Atherectomy