Coronary Artery Disease
Conditions
Interventions
- Coronary PCI guided by OCT (Stent implantation using OCT guidance)
- Coronary PCI guided by Angiography (Stent implantation using OCT guidance)
Sponsors
Coe Jessie
Abbott Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
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 (ischemia in the absence of chest pain or other anginal equivalents), 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: A) High clinical-risk, defined as; i.Medication-treated diabetes mellitus, AND/OR B) 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; i.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), OR -STEMI >24 hours from the onset of ischemic symptoms ii.long or multiple lesions (defined as intended total stent length in any single target vessel >=28 mm), iii.bifurcation intended to be treated with 2 planned stents (i.e. in both the main branch and side branch), and where the planned side branch stent is >= 2.5 mm in diameter by angiographic visual estimation. iv.angiographic severe calcification (defined as angiographically visible calcification on both sides of the vessel wall in the absence of cardiac motion), v.chronic total occlusion (CTO) (enrolment and randomization in this case performed only after successful antegrade wire escalation crossing and pre-dilatation) vi.in-stent restenosis of diffuse or multi-focal pattern. Lesion must be at or within the existing stent margin(s) and have angiographically visually-assessed DS >=70% or DS >=50% with non-invasive or invasive evidence of ischemia 4. All target lesions (those lesions to be randomized) must have a visually estimated or quantitatively assessed %DS of either >=70%, or 50% plus one or more of the following: an abnormal functional test (e.g. fractional flow reserve, stress test) signifying ischemia in the distribution of the target lesion(s) or biomarker positive ACS with plaque disruption or thrombus. 5. All target lesions must be planned for treatment with only >=2.5 mm and <=3.5 mm stents and post-dilatation balloons based on pre-PCI angiographic visual estimation. 6. No more than 2 target lesions requiring PCI are present in any single vessel., and no more than 2 target vessels are allowed. Thus, up to 4 randomized target lesions per patient in a maximum of 2 target vessels are allowed, including branches. The intended target lesions will be declared just prior to randomization. 7. All target lesions intended to be treated by PCI in the target vessel are amenable to OCT-guided PCI (i.e. no lesion-specific angiographic exclusion criteria are present). Example: If a qualifying angiographic high-risk lesion is in the proximal LAD, and there is a second target lesion in the distal LAD which is a focal lesion not otherwise meeting high-risk criteria, both the proximal LAD and distal LAD lesions must be amenable to OCT (e.g. no excessive tortuosity or calcification precluding delivering the OCT catheter), and each lesion must undergo OCT-guided stenting. Otherwise the vessel should be excluded from randomization. 8. Subject must provide written Informed Consent prior to any study related procedure.
Exclusion criteria
Exclusion criteria: 1. STEMI =2 or NYHA class >=3) 5. LVEF 700,000 cells/mm3. 17. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh >= Class B. 18. Subject has a history of bleeding diathesis or coagulopathy, or has had a significant gastro-intestinal or significant urinary bleed within the past six months. 19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.). 20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. 21. Subject has life expectancy <2 years for any non-cardiac cause. 22. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint . 23. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Minimal stent area (MSA) : Post-PCI MSA assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment. - Target vessel failure (TVF): Composite time-to-first event rate of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR) | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT-defined (OCT core laboratory assessed). Subjects in the angiography-guided arm will undergo a post-PCI OCT run, blinded to the operator. Assessed per target lesion. 1)Stent expansion. Stent expansion is defined by the MSA achieved in the proximal and distal stented segments relative to their respective reference lumen areas. The stent length is divided into 2 equal segments (proximal and distal) except for lesions containing a bifurcation (visually estimated side branch >=2.5 mm). When there is a bifurcation present, rather than splitting the stent into two halves, the division occurs at the proximal most side branch. 2)Mean stent expansion (%) (continuous variable): The mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100. 3)Intra-stent plaque protrusion and thrombus 4)Untreated reference segment disease 5)Edge dissections 6)Stent Malapposition 7)Border detection (angiography arm post-PCI only, blinded to investigator) 8)Intra-stent lumen area (intra-stent flow area) 9)Effective lumen area (total flow area) 10)Angiographic Endpoints (QCA). (Angiographic core laboratory assessed). Assessed per target lesion. 11)Device Usage Endpoints (site reported; assessed per subject): 12)Procedure time (first wire insertion to guide catheter removal), fluoroscopy time, radiation exposure 13)Contrast use; contrast induced nephropathy (defined as serum creatinine rise >25% or absolute increase >0.5 mg/dL (44.2micro-mol/L)); need for renal replacement therapy 14)Procedural success (must be present in all treated lesions and vessels) 15)Procedural complications 16)OCT performance success (site reported) (OCT arm only) 17)OCT imaging-related procedural complications (CEC adjudicated) Any procedural complications (e.g. angiographic dissection, perforation, thrombus, acute closure, etc.) requiring any active intervention (e.g. prolonged balloon inflations, additional stent implantation, pericardiocentesis, | — |
Countries
Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Japan, Netherland, New Zealand, Portugal, Singapore, Spain, Switzerland, Taiwan, UK, USA
Contacts
Public ContactKristina Gibbens
Abbott
Outcome results
None listed