Severely calcified coronary stenoses are difficult to treat with percutaneous coronary intervention (PCI) using current techniques and there is little specific evidence on how to best treat these cases. It is hypothesized that balloon lithoplasty is superior to conventional balloons for lesion preparation of severely calcified coronary lesions before stent implantation in terms of procedural failure and 1-year target vessel failure.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years and \< 90 years
* Stable coronary heart disease or non-ST elevation acute coronary syndrome
* PCI planned in severely calcified, non-occluded, de-novo lesion in native vessel. Definition of severe calcifications (minimum 1 of 3 (i-iii)); i. Angiography: Radioopacities of the vessel wall visible on cine images before contrast injection on both sides of the vessel lumen in more than one projection. ii. OCT (before lesion preparation): Maximum calcium 1) angle \>180 degrees AND 2) thickness 0.5mm, AND 3) longitudinal length \>5m m. iii. IVUS (before lesion preparation): Maximum calcium angle \>270 degrees.
* Functional evidence of ischemia (non-invasive stress test or fractional flow reserve) in the target vessel territory or stenosis ≥ 90% by visual estimate
* Target vessel reference diameter visually estimated at 2.5-4 mm with ability to pass a 0.014" guidewire across lesion
* Ability to tolerate dual antiplatelet therapy
* Informed consent
Angiographic exclusion criteria:
* Unprotected left main stenosis
* Chronic total occlusion
* Severely calcified bifurcated lesion with expected need to use two stent technique
* Coronary artery dissection
Clinical exclusion criteria
* ST-segment elevation acute myocardial infarction
* Planned later revascularization in non-study lesions
* Planned cardiovascular intervention within 30 days after study intervention
* Clinical instability including decompensated heart disease
* Life expectancy of less…
What they're measuring
1
Number of patients with combined outcome of strategy failure