TECTONIC CAD IVL IDE Study (NCT06885177) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TECTONIC CAD IVL IDE Study
United States335 participantsStarted 2025-04-01
Plain-language summary
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be at least 18 years of age.
✓. Subject must sign and date a written informed consent form before any study-specific tests or procedures are performed.
✓. Subject is able and willing to comply with all protocol requirements.
✓. Subject has native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI.
✓. For subject with unstable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to the upper reference limit (URL) within 12 hours prior to the procedure.
✓. For subject with stable ischemic heart disease, cardiac biomarker (troponin) must be less than or equal to 1.5 times the URL. Blood for cardiac biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
✓. The target lesion must be a single de novo coronary lesion that has not been previously treated with ANY interventional procedure.
✓. Single de novo target lesion stenosis of protected left main coronary artery (LMCA), or left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with: a. Stenosis of ≥70% and \<100% or b. Stenosis ≥50% and \<70% with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or RFR/iFR \<0.89 (or any other non-hyperemic pressure index), or IVUS or OCT minimum lumen area ≤4.0 mm\^2
Exclusion criteria
✕. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
✕. Subject is a member of a vulnerable population including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
✕. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the Primary endpoint. For the purposes of this criterion, "participation" is defined as being registered in another trial.
✕. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. For subjects with childbearing potential, a urine or blood pregnancy test is required within 7 days prior to index procedure to verify that subject is not pregnant. Note: Investigators should instruct female patients of childbearing potential to use safe contraception for 12 months after the procedure (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release). It is acceptable to include subjects having a sterilized regular partner.
✕. Subject unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months.
✕. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.
✕. Subject experienced an acute MI (either ST-segment elevation myocardial infarction, STEMI or non-ST-segment elevation myocardial infarction, NSTEMI) within 7 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK- MB greater than 1 times the local laboratory's ULN.
What they're measuring
1
Primary Efficacy Endpoint: Procedural success with final mean residual stenosis <50% and without in-hospital TLF.
Timeframe: Within 48 hour post index procedure or prior to discharge, whichever is earlier.
2
Primary Safety Endpoint: TLF at 30-days post index procedure