Clinical trial NCT02671123: Does Co-registration of OCT and Angiography Reduce Geographic Miss of Stent Implantation?
Official title: Evaluation of Effect of Co-registration Between Optical Coherence Tomography (OCT) and Coronary Angiography Onto OCT Guided Percutaneous Coronary Intervention (PCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Geographic miss
timeFrame: Intraoperative
Secondary outcomes:
measure: Number of participants with Residual disease at stented edge
timeFrame: Intraoperative
measure: Number of participants with stent edge dissection
timeFrame: peri procedure
measure: Distance between the planned and actual stent location
timeFrame: Intraoperative
measure: Number of additional stents required
timeFrame: Intraoperative
measure: Procedure time
timeFrame: Intraoperative
measure: Total fluoroscopy time
timeFrame: intraoperative
measure: Total contrast volume
timeFrame: intraoperative
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
Study officials:
affiliation: Chairman of Cardiology St Francis Hospital
name: Richard A Shlofmitz, MD
role: PRINCIPAL_INVESTIGATOR
References: