Clinical Trials Logo

Clinical Trial Summary

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03507777
Study type Interventional
Source St. Jude Medical
Contact Andrew Campbell
Phone 651-756-5538
Email andrew.campbell4@abbott.com
Status Recruiting
Phase N/A
Start date March 26, 2018
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT02115308 - Characterization of Changes in Ventricular Mechanics in Response to Lexiscan Stress Using Tagged Cine Cardiac Magnetic Resonance Imaging Phase 4
Terminated NCT01374555 - Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Recruiting NCT03226262 - FFRangio Accuracy vs. Standard FFR N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography) N/A
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT03518437 - Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging
Active, not recruiting NCT02693158 - The Direct III Post Market Study
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A
Enrolling by invitation NCT02894255 - Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents Phase 4
Terminated NCT02739685 - Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion Phase 4
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A