Does Co-registration of OCT and Angiography Reduce Geographic Miss of Stent Implantation?

NCT ID: NCT02671123

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of this study is to determine whether co-registration of OCT and angiography reduce geographic miss defined as stent edge dissection or significant residual stenosis at stent edge after stent implantation during percutaneous coronary intervention.

Detailed Description

Background: When a stent fails to fully cover the lesion, it is termed "geographic miss" (GM). Optical coherence tomography (OCT) is an intracoronary imaging modality that has higher resolution than conventional intracoronary ultrasound. Although OCT allows identification of the location of the culprit lesion and side branch using automated measures, it is sometimes difficult to identify the exact segment corresponding to angiography. Recently, co-registration of OCT and angiography has become available; however, whether this reduces the incidence of GM during stenting is unknown.

Hypothesis: OCT reduces GM during percutaneous coronary intervention.

Objectives:

1. Determine the incidence of GM defined as residual disease* and significant edge dissection† at proximal and distal reference

2. Determine the incidence of stent dislocation (distance between planned and actual stented place)

3. Determine procedural findings (additional stent, total fluoro time, total contrast volume)

• Minimum lumen area <4.0 mm2 in the presence of significant residual plaque within 5 mm distal and proximal to the stent edge.

• A flap of vessel wall of >60° is seen in ≥2 consecutive cross-section image within 5 mm distal and proximal from stent edge Study Design and Methods: Single-center, prospective, randomized study. Consented subjects who are to undergo percutaneous coronary intervention are divided into 2 groups randomly (OCT with co-registration vs OCT without co-registration). After stent deployment guided by OCT, dissection, residual disease at the stent edge, and distance between planned and actual stent location are assessed using OCT or angiography. Additional stent deployment, procedure time, total fluoroscopy time, and total contrast volume are also evaluated.

Sample size considerations: OCT with co-registration: 100, OCT without co-registration: 100 (α＝0.05, β ＝0.2). In a retrospective evaluation, the incidence of residual disease (lumen area <4.0 mm2 in the presence of significant residual plaque) or significant stent edge dissection was 36% (18/50, 34% [17/50] with residual stenosis, 4% [2/50] with significant edge dissection). Under the assumption that GM occurs in 36% of patients without co-registration and 18% of patients with co-registration, a group of 190 patients yields a power 80% (with a 2-sided α=0.05) to detect a difference in GM between patients with and without co-registration. In order to account for patient drop out and non-evaluable OCT recordings (5%), a total of 200 patients will be enrolled.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Coronary PCI with OCT with Co-Registration

Coronary stenting will be performed with OCT guidance as per local practice. Pre and post stenting procedure will be performed with OCT guidance with the use of the Co-Registration software tool after stent implanted.

Group Type: ACTIVE_COMPARATOR

Coronary PCI with OCT with Co Registration

Intervention Type: PROCEDURE

Co-Registration is an online tool used to take measurements during a stent procedure ( PCI-percutaneous coronary intervention) as part of the OCT ( Optical Coherence Tomography intravascular system. Co Registration software may provide additional imaging details during stent implantation when using OCT.

Coronary PCI with OCT without Co-Registration

Coronary stenting will be performed with OCT guidance as per local practice. Pre and post stenting procedure will be performed with OCT guidance without the use of the Co-Registration software tool after stent implanted.

I

Group Type: PLACEBO_COMPARATOR

Coronary PCI with OCT without Co Registration

Intervention Type: PROCEDURE

Coronary PCI will be performed using OCT ( Optical Coherence Tomography intravascular system) guidance without the Co Registration software tool enabled.

Interventions

Coronary PCI with OCT with Co Registration

Co-Registration is an online tool used to take measurements during a stent procedure ( PCI-percutaneous coronary intervention) as part of the OCT ( Optical Coherence Tomography intravascular system. Co Registration software may provide additional imaging details during stent implantation when using OCT.

Intervention Type: PROCEDURE

Coronary PCI with OCT without Co Registration

Coronary PCI will be performed using OCT ( Optical Coherence Tomography intravascular system) guidance without the Co Registration software tool enabled.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients ≥18 years old who undergo percutaneous coronary intervention per clinical indications.

Exclusion Criteria

• Left main disease
• Ostial lesion at Right Coronary Artery
• Tortuous artery in which OCT is unable to pass
• Lesion at bypass graft
• In-stent restenosis
• Chronic total occlusion
• Cardiogenic shock (sustained [>10 min] systolic blood pressure <90 mm Hg in absence of inotropic support or the presence of an intra-aortic balloon pump)
• Acute phase heart failure
• Sustained ventricular arrhythmias
• Known ejection fraction <35%
• Known severe valvular heart disease Known severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.72 m2)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioVascular Research Foundation, Korea

OTHER

Sponsor Role: collaborator

St. Francis Hospital, New York

OTHER

Sponsor Role: lead

Responsible Party

Richard A. Shlofmitz, MD

Chairman of Cardiology- Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard A Shlofmitz, MD

Role: PRINCIPAL_INVESTIGATOR

Chairman of Cardiology St Francis Hospital

Locations

St. Francis Hospital

Roslyn, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Richard A Shlofmitz, MD

Role: CONTACT

richard.shlofmitz@chsli.org

516-390-9640

Elizabeth S Haag, RN MPA

Role: CONTACT

elizabeth.haag@chsli.org

516 562-6790

Facility Contacts

Elizabeth S Haag, RN, MPA,CCRP

Role: primary

elizabeth.haag@chsli.org

516-562-6790

Lyn Santiago, RN,CCRC

Role: backup

lyn.santiago@chsli.org

516 562-6790

Other Identifiers

16-02

Identifier Type: -

Identifier Source: org_study_id