OPtical Coherence Tomography (OCT) Compared to Intravascular Ultrasound (IVUS) and Angiography to Guide Coronary Stent Implantation: a Multicenter RandomIZEd Trial in PCI

Completed

• Conditions: Coronary Artery Disease - Disease of the heart vessels; 10011082

• Registration Number: NL-OMON42441
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

General Inclusion Criteria:
1) Age >= 18 years.
2) Patient with an indication for PCI
3) Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES);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) Total lesion length <40mm

Exclusion Criteria

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 or requiring pressors or hemodynamic support, including 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 LVEF <30%
13) Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)
14) Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Endpoint (powered).<br /><br>Post-PCI MSA assessed by OCT in each randomized arm, measured at the<br /><br>independent OCT core laboratory blinded to imaging modality assignment.<br /><br>Testing will be done in a hierarchal manner as follows:<br /><br>1. Non-inferiority of OCT guided stenting vs. IVUS guided stenting<br /><br>2. Superiority of OCT guided stenting vs. Angiography guided stenting<br /><br>3. Superiority of OCT guided stenting vs. IVUS guided stenting<br /><br><br /><br>Primary Safety Endpoint (non-powered).<br /><br>Procedural MACE defined as procedural complications (angiographic dissection,<br /><br>perforation, thrombus, and acute closure) requiring active interventions<br /><br>(prolonged balloon inflations, additional stent implantation, or<br /><br>pericardiocentesis).</p><br>