N/A
N=37
Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI
Coronary Artery Disease (CAD)
Bottom Line
View on ClinicalTrials.gov: NCT03021577 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Index of Microcirculatory Resistance (IMR) — 15; 25 mmHg·s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Orbital Atherectomy System (OAS) (Device); Rotablator Rotational Atherectomy System (Device); Magnetic Resonance Imaging (MRI) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Index of Microcirculatory Resistance (IMR) |
15; 25 | — |
| PRIMARY Fractional Flow Reserve (FFR) |
0.85; 0.88 | — |
| PRIMARY Coronary Flow Reserve (CFR) |
1.9; 2.3 | — |
Summary
The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older generation rotational atherectomy (RA) due to differences in the mechanism of athero-ablation.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Patient with an indication for PCI including:
- Angina (stable or unstable),
- Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),
- Non-ST Segment Elevation Myocardial Infarction (NSTEMI)
- Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
- Signed written informed consent
- Heavily calcified (severe)lesions necessitating atherectomy.
Angiographic inclusion criteria:
- The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤4.00 mm.
- Lesion length between 20 mm and 50mm
Exclusion Criteria
- Estimated creatinine clearance 1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
- Subject is intubated.
- Known left ventricular ejection fraction (LVEF) 30)
Angiographic Exclusion Criteria:
- Lesion length 30)
Data sourced from ClinicalTrials.gov (NCT03021577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.