TECTONIC CAD IVL IDE Study for Coronary Artery Disease
This study is testing the Abbott Coronary IVL System, a new device, to treat severely hardened (calcified) and narrowed (stenotic) arteries in people with coronary artery disease. The system uses a special type of energy (intravascular lithotripsy, IVL) to prepare the artery before a stent is placed. Researchers want to see if this system can successfully open the artery to less than 50% blockage without serious problems within 48 hours or before leaving the hospital. They will also track any major problems within 30 days. You might be able to join if you are at least 18 years old and have coronary artery disease that needs treatment. The study is currently recruiting 335 participants across the US.
- Study design
- This is a single-arm, open-label study, meaning all participants will receive the Abbott Coronary IVL System and both you and your doctors will know what treatment you are getting. It plans to enroll 335 participants.
- What's involved
- Participants will receive treatment with Abbott's Coronary IVL System followed by stenting.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 30 days after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TECTONIC CAD IVL IDE Study
At a glance
Conditions
Where it's being run
40 sites across 21 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Primary Efficacy Endpoint: Procedural success with final mean residual stenosis <50% and without in-hospital TLF.Within 48 hour post index procedure or prior to discharge, whichever is earlier.
The primary effectiveness endpoint is procedural success that is defined as stent delivery with final mean residual stenosis \<50% (core laboratory assessed) and without in-hospital TLF.
- Primary Safety Endpoint: TLF at 30-days post index procedure30-days post index procedure
The primary safety endpoint is TLF (Target lesion failure) defined as a composite of Cardiac Death, TV-MI (Target vessel myocardial infarction), which includes peri-procedural myocardial infarction (PPMI) defined by ARC-2 and spontaneous MI defined by the fourth universal definition of MI (UDMI), and CD-TLR (clinically driven target lesion revascularization)