TECTONIC CAD

BACKGROUND: Severe coronary calcification complicates percutaneous coronary intervention by limiting lesion compliance and impairing stent expansion. OBJECTIVES: To evaluate the safety and effectiveness of the SonicForce Coronary Intravascular Lithotripsy System (Abbott Vascular) in severely calcified de novo coronary lesions. METHODS: TECTONIC CAD intravascular lithotripsy investigational device exemption (NCT06885177) was a prospective, multicenter, single-arm study of 335 patients at 40 U.S. CENTERS: The primary safety endpoint was 30-day target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. The primary effectiveness endpoint was procedural success. Each endpoint was tested against a prespecified performance goal. A prespecified optical coherence tomography (OCT) substudy evaluated calcium modification and stent expansion. RESULTS: , with stent expansion of 95.9% ± 18.6%. Calcium fracture was identified in 62.5% (50 of 80) of lesions after intravascular lithotripsy and 66.3% (53 of 80) after stenting. CONCLUSIONS: TECTONIC CAD met both prespecified coprimary safety and effectiveness endpoints, demonstrating low 30-day target lesion failure and high procedural success. OCT demonstrated calcium fracture and favorable stent expansion at maximum contiguous calcium.

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Publication Details

Journal
JACC: Cardiovascular Interventions
Published
2026-11-01
DOI
https://doi.org/10.1016/j.jcin.2026.10.002
Primary Topic
Coronary Interventions and Diagnostics
Type
article
Field-Weighted Citation Impact
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article

TECTONIC CAD

Osama Mukarram, Brad J. Martinsen, Louis Verreault‐Julien, Sandeep C. Pingle et al.
1 links
JACC: Cardiovascular Interventions
Coronary Interventions and Diagnostics
article

TECTONIC CAD

Osama Mukarram, Brad J. Martinsen, Louis Verreault‐Julien, Sandeep C. Pingle, Allen Jeremias, Gopi Manthripragada, Evan S. Shlofmitz, Ziad A. Ali, Anderson P. Mehrle, Nirat Beohar, Azeem Latib, Eric Alexander Secemsky, James D. Flaherty, Kathleen E. Kearney, Salman Saleem Allana, Jeffrey J. Popma, Carlye Kraemer, Akiko Maehara, Bassem Chehab, Eric Alan Osborn, Ethan C Korngold, Suhail Y. Dohad, Yader Sandoval, Issam Moussa, Ben-Dor Itsik, Robert Stoler, Mubbasher Syed, Torrey Schmidt, William Nicholson, Jonathan Rosenberg, Hayder Hashim, Sameh Sayfo, Rebecca Chester, Oliver Abela, Calvin Choi, Christopher Haddad, Pratik Sandesara, Gayle Johnson, Jennifer M. Meinen, Rudy Haddad, James Smith, Salvatore Mannino, Daniel Kiss
article en

Abstract

BACKGROUND: Severe coronary calcification complicates percutaneous coronary intervention by limiting lesion compliance and impairing stent expansion. OBJECTIVES: To evaluate the safety and effectiveness of the SonicForce Coronary Intravascular Lithotripsy System (Abbott Vascular) in severely calcified de novo coronary lesions. METHODS: TECTONIC CAD intravascular lithotripsy investigational device exemption (NCT06885177) was a prospective, multicenter, single-arm study of 335 patients at 40 U.S. CENTERS: The primary safety endpoint was 30-day target lesion failure, defined as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. The primary effectiveness endpoint was procedural success. Each endpoint was tested against a prespecified performance goal. A prespecified optical coherence tomography (OCT) substudy evaluated calcium modification and stent expansion. RESULTS: , with stent expansion of 95.9% ± 18.6%. Calcium fracture was identified in 62.5% (50 of 80) of lesions after intravascular lithotripsy and 66.3% (53 of 80) after stenting. CONCLUSIONS: TECTONIC CAD met both prespecified coprimary safety and effectiveness endpoints, demonstrating low 30-day target lesion failure and high procedural success. OCT demonstrated calcium fracture and favorable stent expansion at maximum contiguous calcium.

JACC: Cardiovascular Interventions
Cedars-Sinai Medical Center (US), MedStar Washington Hospital Center (US), Geisinger Medical Center (US), Albert Einstein College of Medicine (US), Carle Foundation Hospital (US), Beth Israel Deaconess Medical Center (US), Abbott Northwestern Hospital (US), Ascension (US), Allina Health (US), Montefiore Medical Center (US), NorthShore University HealthSystem (US), Harvard University (US), Columbia University Irving Medical Center (US), Harrisburg Hospital (US), Emory University Hospital (US), University of Florida Health (US), WellStar Kennestone Hospital (US), University of Washington Medical Center (US), Glenbrook Hospital (US), Northwestern Memorial Hospital (US), St. Francis Hospital (US), Mount Sinai Medical Center (US), Heart Hospital Baylor Plano (US), Kaiser Permanente San Francisco Medical Center (US), First Coast Cardiovascular Institute (US), HonorHealth (US), Minneapolis Heart Institute Foundation (US), AdventHealth Tampa (US), Cedars-Sinai Smidt Heart Institute (US), Cardiovascular Research Foundation (US), Ascension Via Christi (US), Baylor Scott & White Health (US), Jersey Shore University Medical Center (US), Abbott Vascular (United States) (US), University of Florida Health Science Center (US), The University of Texas Southwestern Medical Center (US)
Abbott Vascular
Openalex Percentile: Top 10%
Coronary Interventions and Diagnostics
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