Experimental Treatment for Coronary Artery Disease
(TECTONIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment for individuals with coronary artery disease, which affects the arteries supplying blood to the heart. Participants will receive a new device treatment called Abbott's Coronary IVL System, a type of intravascular lithotripsy device, followed by a stent to help keep the artery open. The trial seeks individuals who have not undergone any prior procedures on a specific coronary artery lesion (area of narrowing). This trial may suit those who have experienced chest pain or other symptoms related to coronary artery disease and have not had a recent heart attack. As an unphased trial, this study offers the opportunity to contribute to innovative research that could enhance future treatment options for coronary artery disease.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be able to tolerate dual antiplatelet therapy (aspirin and another medication like clopidogrel) for at least 6 months.
What prior data suggests that the Abbott Coronary IVL System is safe for use?
Research has shown that Abbott's Coronary IVL System is generally well-tolerated. In a study with 509 patients, only about 6% experienced complications during the procedure. Notably, only 1% of these issues occurred immediately after using the IVL system. This indicates that while some risks exist, most patients do not encounter serious problems right after treatment.12345
Why are researchers excited about this trial?
Unlike the standard treatments for coronary artery disease, which typically involve balloon angioplasty or atherectomy, the Abbott Coronary IVL System uses a novel method called intravascular lithotripsy (IVL). This technique employs sound waves to break up calcium deposits in the arteries, making it easier to place a stent. Researchers are excited because this approach could be gentler on the arteries, potentially reducing the risk of complications and improving outcomes for patients with heavily calcified lesions.
What evidence suggests that the Abbott Coronary IVL System is effective for coronary treatment?
Research has shown that Abbott's Coronary Intravascular Lithotripsy (IVL) System, which participants in this trial will receive, is designed to treat severely blocked arteries, a common issue in heart disease. In a study with 509 patients, only about 6% experienced complications during the procedure, and just 1% of these occurred immediately after using IVL. This suggests that the treatment is effective and safe for most individuals. The IVL System uses sound waves to break up calcium in the arteries, facilitating stent placement and improving blood flow. Early results are promising, indicating that IVL can benefit people with heart disease.12345
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with Abbott's Coronary IVL System followed by stenting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Experimental
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive treatment with Abbott's Coronary IVL System followed by stenting.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Citations
1.
abbott.mediaroom.com
abbott.mediaroom.com/2025-03-24-Abbott-Initiates-New-Intravascular-Lithotripsy-Clinical-Trial-to-Improve-Outcomes-in-Patients-with-Coronary-Artery-DiseaseAbbott Initiates New Intravascular Lithotripsy Clinical Trial to ...
The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the US.
2.
cardiovascular.abbott
cardiovascular.abbott/us/en/patients/treatments-therapies/coronary-artery-disease/ivl-trial.htmlTectonic CAD IVL IDE Study | Abbott
The purpose of this study is to check if the Coronary IVL System is safe and effective. The system is designed to treat arteries that are severely blocked by ...
NCT06885177 | TECTONIC CAD IVL IDE Study
The TECTONIC CAD IVL IDE Study is a prospective, single-arm, open-label, multi-center study to evaluate the safety and effectiveness of the Abbott Coronary ...
Breaking Down the Risk During Intravascular Lithotripsy
Among 509 patients, 33 (6%) experienced procedural complications, and only 6 of these (1%) occurred immediately after IVL use. The most common ...
Abbott Initiates New Intravascular Lithotripsy Clinical Trial ...
The TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) clinical trial will enroll up to 335 people in 47 sites in the US.
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