To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.
At present age, there are few real-world data published about the use of intravascular lithotripsy. Its safety and possible procedural complications remain unclear, and the effects of combination with other plaque-modification devices are unknown. Finally, there are few data about long-term outcomes in the real-life setting. Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with Stable CAD or Acute Coronary Syndromes, that are suitable for percutaneous coronary intervention (PCI). Approximately 400 subjects at 20 sites will be enrolled. Subjects will be followed through discharge, 30 days, 6 and 12 months
Study Type
OBSERVATIONAL
Enrollment
400
Intravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent.
Number of Participants Who Experienced Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure.
The primary safety endpoint was freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. Definition of MACE: Composite of * cardiac death; * myocardial infarction (MI): CK-MB level \>3 times the upper limit of lab normal (ULN) value with or without new pathologic Q waves at discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI) * target vessel revascularization: revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
Time frame: within 30 days of index procedure
Number of Participants With Procedural Success
The primary effectiveness endpoint was procedural success defined as stent delivery with a residual stenosis \<20% (Image Core Laboratory-Assessed) and without intra-procedural MACE.
Time frame: within 30 days of index procedure
Residual stenosis < 30%
Stent delivery with ≤30% residual stenosis and without serious angiographic complications.
Time frame: intra-procedural
Serious angiographic complications
Severe dissection (Type D to F), perforation, abrupt closure, persistent slow flow or persistent no reflow, pericardial effusion, access-site complications (in-hospital).
Time frame: intra-procedural
MACE at 6 and 12 months
Cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR).
Time frame: at 6 and 12 months
Target lesion failure (TLF)
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Cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods at 30 days, 6 and 12 months.
Time frame: at 30 days, 6 and 12 months.
Other clinical secondary outcomes
All death, cardiac death, MI, target vessel MI (TV-MI), ischemia-driven TVR (ID-TVR), ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)
Time frame: at 30 days, 6 months nd 12 months.
Intraprocedural secondary outcome
1.Minimal Lumen Diameter pre-stenting and post-stenting (mm at QCA evaluation)
Time frame: intra-procedure
Intraprocedural secondary outcome
Minimal Lumen Area (mm2) pre-stenting and post stenting (IVUS/OCT)
Time frame: intra-procedure
Intraprocedural secondary outcome
QFR value at the end of the procedure
Time frame: intra-procedure