Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments coronary pci guided by ivus, coronary pci guided by oct, coronary pci guided by angiography
Sponsor St. Jude Medical
Collaborator Cardiovascular Research Foundation, New York
Start date May 2015
End date July 2016
Trial size 450 participants
Trial identifier NCT02471586, SJM-CIP-10034

Summary

To demonstrate the safety and efficacy of an OCT guided strategy for stent implantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation. At the end of the procedure, a final IVUS imaging run must be performed. After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.
coronary pci guided by ivus Intravascular Ultrasound
Imaging type
(Active Comparator)
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation. At the end of the procedure, a final OCT imaging run must be performed.
coronary pci guided by oct Optical Coherence Tomography
Imaging type
(Active Comparator)
Intervention = Coronary stenting with planned drug eluting stent (DES). Stenting will be performed with angiography guidance according to local standard practice. At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.
coronary pci guided by angiography
Imaging type

Primary Outcomes

Measure
Primary Efficacy Endpoint (powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Primary Efficacy Endpoint (powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Primary Efficacy Endpoint (powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Primary Safety Endpoint (non-powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Secondary Outcomes

Measure
Acute procedural success
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Post-PCI stent expansion (%)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Mean stent expansion (%)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Intra-stent plaque protrusion and thrombus
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Untreated reference segment disease
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Edge dissections
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Stent Malapposition
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Border detection (OCT arm only)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Altered clinical decision making on the basis of the post-stent imaging run
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Intra-stent Lumen Area (Intra-stent Flow Area)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Effective Lumen Area (Total Flow Area)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
IVUS Secondary Endpoints (IVUS Arm Only): Comparison to Blinded OCT Run (not-powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
IVUS Secondary Endpoints (IVUS Arm Only): Comparison to Blinded OCT Run (not-powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
IVUS Secondary Endpoints (IVUS Arm Only): Comparison to Blinded OCT Run (not-powered)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA))
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA))
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA))
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA))
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Non OCT Secondary Endpoints (Angiographic Endpoints (QCA))
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural Endpoints (site reported)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural Endpoints (site reported)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural Endpoints (site reported)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural Endpoints (site reported)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural Endpoints (site reported)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedural Endpoints (site reported)
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Additional Procedural and Clinical Endpoints
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Additional Procedural and Clinical Endpoints
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Additional Procedural and Clinical Endpoints
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Additional Procedural and Clinical Endpoints
time frame: Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Eligibility Criteria

Male or female participants at least 18 years old.

General Inclusion Criteria: 1. Age ≥ 18 years. 2. Patient with an indication for PCI including: - Angina (stable or unstable), - Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or fractional flow reserve (FFR) ≤0.80 must be present), - Non-ST segment elevation myocardial infarction (NSTEMI), or - Recent ST segment elevation myocardial infarction (STEMI) (>24 hours from initial presentation and stable). 3. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES) 4. Signed written informed consent Angiographic inclusion criteria: 1. The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm. 2. Lesion length <40mm Note: Overlapping stents are allowed General Exclusion Criteria: 1. Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis 2. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital. 3. PCI within 24 hours preceding the study procedure. 4. PCI of a lesion within the target vessel within 12 months prior to the study procedure 5. Planned use of bare metal stent (BMS) 6. Planned use of bioresorbable vascular scaffold (BVS) 7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including Intra-aortic balloon pump (IABP), at time of procedure. 8. Mobitz II second degree or complete heart block 9. Malignant ventricular arrhythmias requiring treatment 10. Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema 11. Subject is intubated. 12. Known left ventricular ejection fraction (LVEF) <30%. 13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis) 14. Cerebrovascular accident ( CVA) or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA. 15. Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes. 16. Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated. 17. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint. 18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment). Angiographic Exclusion Criteria: 1. The presence of any non-study lesion in the target vessel with angiographic diameter stenosis >50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure Note: Patients may have non-study lesions in a non-target vessel that require PCI. These lesions must be treated prior to randomization, with the procedure being successful and uncomplicated. Alternatively non-study lesions in a non-target vessel may be treated >24 hours prior to or >48 hours after the study procedure. Successful and uncomplicated procedure is defined as <30% visually estimated residual diameter stenosis, Thrombolysis In Myocardial Infarction (TIMI) Grade 3 flow, no dissection ≥ National Heart, Lung and Blood Institute (NHLBI) type C, no perforation, no prolonged chest pain or ST segment elevation or depression (>30 minutes), no peri-procedural myocardial infarction (MI) as measured by creatine kinase-MB (CKMB) >5x upper limits of normal (ULN) or troponin >35x ULN. 2. Left main diameter stenosis ≥30% or left main PCI planned. 3. Study target lesion in a bypass graft 4. Ostial right coronary artery (RCA) study target lesion 5. Chronic total occlusion (TIMI flow 0/1) study target lesion 6. Bifurcation study lesion with a planned dual stent strategy 7. In-stent restenosis study target lesion 8. Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)

Additional Information

Official title ILUMIEN III: OPTIMIZE PCI OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in Percutaneous Coronary Intervention (PCI)
Principal investigator Ziad Ali, MD
Description This is a prospective, post market, international, multi-center, randomized trial. Patients undergoing coronary angiography with possibility of PCI will be consented to participate in the study. Patients who provide informed consent and who meet all eligibility criteria will be randomized 1:1:1 to undergo PCI with either OCT, IVUS, or Angiography guidance. All patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography and IVUS groups 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 and 1 year.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.