Coronary Artery Disease Clinical Trial
Official title:
A Single Center, Randomized Trial of Treatment Strategies for Obstructive Calcified Coronary Lesions: Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions (ECSPAND)
Design: The proposed study is a randomized study comparing the relative effectiveness of
three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs
using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA)
obtained with IVUS or OCT. Patients will be blinded to treatment assignment for the duration
of the study.
Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL 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.
Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent
advancement of the OAS according to the manufacturer's guidelines.
Control: Patients who are randomized to SBS will undergo coronary wiring and balloon
inflation with SBS performed by standard technique under intravenous infusion of heparin.
SBS will be used according to the AngioSculpt manufacturer's guidelines.
Duration: 30 days follow-up.
The primary trial objective is to determine which of the three treatment strategies for
treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio
of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT
(primary study endpoint).
The secondary objectives are to compare the following:
1. Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as
determined by IVUS or OCT (secondary endpoint)
2. Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)
3. Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined
by quantitative coronary angiography (secondary endpoint)
4. Incidence of major adverse cardiac events (death, myocardial infarction, target vessel
revascularization) during 30 days of follow-up (secondary endpoints)
5. Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)
n/a
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