NCT02671123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

January 26, 2016

Last Update Submit

February 4, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Geographic miss

    Geographic miss defined as evidence of residual disease at stent edge or significant edge dissection after stent deployment

    Intraoperative

Secondary Outcomes (7)

  • Number of participants with Residual disease at stented edge

    Intraoperative

  • Number of participants with stent edge dissection

    peri procedure

  • Distance between the planned and actual stent location

    Intraoperative

  • Number of additional stents required

    Intraoperative

  • Procedure time

    Intraoperative

  • +2 more secondary outcomes

Study Arms (2)

Coronary PCI with OCT with Co-Registration

ACTIVE COMPARATOR

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.

Procedure: Coronary PCI with OCT with Co Registration

Coronary PCI with OCT without Co-Registration

PLACEBO COMPARATOR

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

Procedure: Coronary PCI with OCT without Co Registration

Interventions

Coronary PCI with OCT with Co RegistrationPROCEDURE

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 with Co-Registration
Coronary PCI with OCT without Co RegistrationPROCEDURE

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

Coronary PCI with OCT without Co-Registration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Richard A Shlofmitz, MD

    Chairman of Cardiology St Francis Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard A Shlofmitz, MD

CONTACT

516-390-9640richard.shlofmitz@chsli.org

Elizabeth S Haag, RN MPA

CONTACT

516 562-6790elizabeth.haag@chsli.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Cardiology- Principal Investigator

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

US(1)