Mount Sinai Clinical Trial Tests Hybrid Technique for Calcified Coronary Nodules
Combining rotational atherectomy with intravascular lithotripsy before placing a coronary stent expands stents 19 percent more effectively than using lithotripsy alone, according to randomized clinical trial results. The novel treatment approach, tested on patients with hard calcium deposits known as calcified nodules, aims to overcome the mechanical resistance that frequently causes stent underexpansion. Lead researcher Annapoorna S. Kini, MD, Director of the Cardiac Catheterization Lab at The Mount Sinai Hospital, presented the NODULE-SHOCK study findings on November 1, 2026, during the Transcatheter Cardiovascular Therapeutics conference in San Diego. The results were simultaneously published in JACC: Cardiovascular Interventions.
Shaving and Shaking Complex Coronary Lesions
Calcified nodules present rigid and irregular structures that prevent standard stents from expanding fully. To address this resistance, Dr. Kini and her team at The Mount Sinai Hospital evaluated the “Shave and Shake” concept, which pairs rotational atherectomy—using a rotating burr to modify protruding calcium—with intravascular lithotripsy, which deploys shockwave pulses from a specialized balloon to fracture deeper calcium deposits. Researchers enrolled 120 patients with severely calcified coronary arteries, assessing lesion morphology using optical coherence tomography.
Stent Expansion Comparison in the NODULE-SHOCK Trial
Across both cohorts, investigators recorded no deaths, heart attacks, repeat procedures on the treated artery, or stent thromboses during the initial 30-day follow-up period.
Testing Additional Shockwave Pulses on Severe Calcification
In a separate cohort of 54 patients with severely calcified lesions lacking nodules, the Mount Sinai research team investigated whether delivering extra intravascular lithotripsy pulses improved outcomes. Researchers assigned patients to a maximum-pulse strategy and a physician-selected dose group. Patients in the maximum-pulse group received an average of 114 pulses, yet final stent area was similar, measuring 5.50 mm² for the high-pulse group versus 5.56 mm² for the physician-selected group. Dr. Kini noted that these findings demonstrate how choosing the right treatment for the right type of calcium yields better results than simply increasing treatment intensity.
Frequently Asked Questions About the Mount Sinai Calcium Study
What is a calcified nodule in a coronary artery?
Calcified nodules are hard, irregular calcium deposits that protrude into coronary arteries, creating extreme mechanical resistance that prevents standard stents from expanding fully during procedures. They are detected using advanced intravascular imaging.
What does the Shave and Shake
method involve?
The method combines rotational atherectomy to modify protruding calcium with intravascular lithotripsy to fracture deeper calcium deposits using shockwave pulses. This dual technique prepares complex lesions for optimal stent placement.
Did extra shockwave pulses improve stent expansion in non-nodule lesions?
No, the NODULE-SHOCK study found that delivering an average of 114 pulses did not improve final stent expansion compared to the standard physician-selected dose of approximately 75 pulses.
Where were the trial results published?
The findings were presented at the Transcatheter Cardiovascular Therapeutics conference in San Diego and simultaneously published in JACC: Cardiovascular Interventions on November 1, 2026.
Mount Sinai Fuster Heart Hospital at The Mount Sinai Hospital ranks No. 5 nationally for cardiology, heart and vascular surgery, according to U.S. News & World Report.
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