NCT03171311

The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)

European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,201 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

Detailed description

Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results. It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome. Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI. Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique. Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).

Conditions

• Ischaemic Heart Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Angiographic guided PCI	Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
PROCEDURE	OCT guided PCI	OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans

Timeline

• Start date: 2017-07-05
• Primary completion: 2022-03-25
• Completion: 2029-05-01
• First posted: 2017-05-31
• Last updated: 2023-06-22

Locations

38 sites across 13 countries: Belgium, Denmark, Estonia, Finland, Germany, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Sweden, United Kingdom