HVP_Ilumien IV

HVP Ilumien IV Optimal PCI OPtical Coherence Tomography (OCT) Guided Coronary Stent Implantation Compared to Angiography: a Multicenter Randomized TriaL in PCI.

This is a prospective, single-blind clinical investigation randomizing subjects to OCT-guided coronary stent implantation vs. angiography-guided coronary stent implantation in a 1:1 ratio. The clinical investigation will be conducted at approximately 125 centers in North America (US and Canada), Europe, Middle East and Asia-Pacific.

All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days, 1 year, and 2 years.

Key Inclusion Criteria:

1.Subject must be at least 18 years of age.
2.Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, or acute myocardial infarction) suitable for elective PCI.
3.Patients undergoing planned Xience stent implantation during a clinically indicated PCI procedure meeting one or more of the following criteria:
◦High clinical-risk, defined as
Medication-treated diabetes mellitus, AND/OR
◦High angiographic-risk lesion(s), with at least one target lesion in each target vessel planned for randomization meeting at least one of the following criteria;

4.Target lesion is the culprit lesion responsible for either:
◾NSTEMI, defined as a clinical syndrome consistent with an acute coronary syndrome and a minimum troponin of 1 ng/dL (may or may not have returned to normal), and >1 mm ST-segment deviation and/or dynamic T wave changes at rest within 7 days, OR
◾STEMI >24 hours from the onset of ischemic symptoms

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
N/A
NCT03507777
Heart and Vascular
Coronary Artery Disease
Jason Wollmuth, M.D.
Abbott Vascular
Heather Aiona
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center
  • TOC Gateway - Heart Clinic