Coronary Artery Disease Clinical Trial
Official title:
Randomized Comparison of Rotational Atherectomy vs INtravascular Lithotripsy for Plaque Modification Before Stent implantatiOn in Patients With Severely Calcified Coronary Lesions: The RAINBOW Trial
Preliminary experiences show that IVL is promising for achieving an effective plaque
modification at time of PCI.
However, uncertainty about the optimal tool to select in case of calcification of coronary
lesions exists, as no randomized comparisons between rotational atherectomy and intravascular
lithotripsy have been carried out so far.
The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive
plaque modification with rotational atherectomy vs. intravascular lithotripsy before
placement of a drug-eluting stent.
Calcification of the coronary lesion is challenging during percutaneous coronary intervention
(PCI) since it can cause the balloon dilation to fail with subsequent incomplete and
asymmetrical stent expansion. Also, calcified coronary lesions are associated with increased
risk of adverse events after PCI, such as stent restenosis and thrombosis.
Several devices and techniques have been proposed to treat severely calcified coronary
lesions. For many years, modification of these lesions with rotational atherectomy has been
considered the gold standard to ease the process of angioplasty and PCI. Recently,
intravascular lithotripsy (IVL) has been proposed as an alternative to rotational atherectomy
for the treatment of calcified de-novo coronary lesions. The Shockwave Medical Coronary Rx
Intravascular Lithotripsy (IVL) System (Shockwave Medical Inc., Fremont, California, USA) is
a novel balloon catheter-based device able to disrupt calcified lesions using technology like
lithotripsy for kidney stones. Preliminary experiences show that IVL is promising for
achieving an effective plaque modification at time of PCI.
However, uncertainty about the optimal tool to select in case of calcification of coronary
lesions exists, as no randomized comparisons between rotational atherectomy and intravascular
lithotripsy have been carried out so far.
The aim of this pilot randomized trial is to evaluate the efficacy and safety of intensive
plaque modification with rotational atherectomy vs. intravascular lithotripsy before
placement of a drug-eluting stent.
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