Treatment in Calcified Coronary Disease Clinical Trial
Official title:
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
The trial will be composed of two cohorts: - Patients treated with up-front rotational atherectomy - Patients in whom atherectomy is not planned Randomization to either cutting balloon angioplasty or intravascular lithotripsy will occur as follows in the 2 cohorts: - After rotational atherectomy is safely completed In the rotational atherectomy arm - After safe and successful wire crossing in patients in whom atherectomy is not planned. The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy in each cohort with regards to the primary endpoint of post-procedural stent area as measured by intravascular imaging at the site of maximal calcification. ;