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

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of Effect of Co-registration Between Optical Coherence Tomography (OCT) and Coronary Angiography Onto OCT Guided Percutaneous Coronary Intervention (PCI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02671123
• Other study ID #: 16-02
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2016
• Last updated: February 4, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: St. Francis Hospital, New York
• Contact: Richard A Shlofmitz, MD
• Phone: 516-390-9640
• Email: richard.shlofmitz[@]chsli.org
• Is FDA regulated: No
• Health authority: United States of America:St Francis Hospital Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	St. Francis Hospital	Roslyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Francis Hospital, New York	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geographic miss	Geographic miss defined as evidence of residual disease at stent edge or significant edge dissection after stent deployment	Intraoperative	No
Secondary	Number of participants with Residual disease at stented edge	Residual disease at stent edge will defined as minimum lumen area within 5mm from the stent edge evaluated by OCT. This measurement will be analyzed by a core lab independently who will be blinded for randomization.	Intraoperative	No
Secondary	Number of participants with stent edge dissection	Stent edge dissection will be defied as a flap of vessel wall and further categorized as intimal dissection, medial dissection, intramural hematoma, or extra-medial dissection. Minimum lumen area, angle of dissection flap, and length of dissection will be measured by OCT by a core lab who is blinded to the randomization.	peri procedure	No
Secondary	Distance between the planned and actual stent location	Distance between the planned and actual stent location will be defined as the distance between the center of planned stent location and the center of actual stent location which will be recorded on the OCT software and analyzed by a core lab who is blinded to the randomization.	Intraoperative	No
Secondary	Number of additional stents required	This will be measured as number of participants with additional stent required.	Intraoperative	No
Secondary	Procedure time	time of PCI procedure defined as time vascular access obtained until guide catheter removed from access site.	Intraoperative	No
Secondary	Total fluoroscopy time	total amount of fluoroscopy time used during procedure	intraoperative	No
Secondary	Total contrast volume	total mount of contrast in ml used during entire PCI procedure	intraoperative	No