Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions (ECSPAND)
Atherosclerosis, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Coronary Atherectomy, percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Clinical indication for coronary intervention such as ischemic symptoms and/or a positive functional study
- Found to have a de novo severe calcification (radio opacities noted without cardiac motion on contrast injection, lesion length >15 mm, or presence of >270° calcification on one cross-sectional view of IVUS) in a native coronary artery on fluoroscopy or IVUS
Exclusion Criteria:
- Subject is currently participating in an investigational device or pharmaceutical treatment protocol
- Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
- Need for revascularization of multiple lesions during the index PCI
- Unprotected left main (>50%) or equivalent left main disease
- Non-calcified lesions
- Chronic total occlusions, extreme lesion tortuosity including Type B/C lesions
- Severe left ventricular dysfunction (ejection fraction <25%)
- History of bleeding diathesis or coagulopathy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Rotational atherectomy
Orbital atherectomy
Scoring balloon system
RA protocol: After IVUS protocol, patients who are randomized to RA will undergo coronary wiring of the target lesion and subsequent advancement of the RA burr. The RA system is performed using standard technique under intravenous infusion of heparin. The atherectomy burr size will be determined by the operator.
OAS protocol: After IVUS protocol, patients who are randomized to OAS will undergo coronary wiring of the target lesion and subsequent advancement of the OAS according to the manufacturer's guidelines.
SBS protocol: After IVUS protocol, patients who are randomized to SBS will undergo coronary wiring of the target lesion and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the manufacturer's guidelines.