Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions

Inclusion criteria

• Radiography inclusion criteria

• the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis >20% after stenting and 16-atm dilatation with a post-dilatation balloon;
• target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
• target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);

General inclusion criteria

• subjects at the age between ≥18 and ≤80 years old;
• patients with symptoms or evidence of myocardial ischaemia;
• subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.

Exclusion criteria

• Radiography exclusion criteria

• in-stent lesions;
• For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);
• Target lesions were total occlusive lesions (acute or chronic), long lesions (>30 mm), lesion vessel reference diameters >4.0 mm, and lesion angiomatous dilatation;

General inclusion criteria

• Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;
• Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
• Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
• Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
• Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
• Patients who plans to accept selective operation within 1 year;
• Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
• Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.