Recruiting

Observational Study

Sponsor:

St. Francis Hospital, New York

Code:

NCT02671123

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary PCI with OCT with Co Registration

Coronary PCI with OCT without Co Registration

Study Details

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.

Conditions

Coronary Artery Disease

Study ID

NCT02671123

Start date

Feb, 2016

Status verified date

Feb, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: 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

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.

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.

Primary outcome measure

  • Geographic miss [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Richard A Shlofmitz, MD

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

Elizabeth S Haag, RN MPA

516 562-6790elizabeth.haag@chsli.org

Locations

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Elizabeth S Haag, RN, MPA,CCRP

516-562-6790elizabeth.haag@chsli.org

Lyn Santiago, RN,CCRC

516 562-6790lyn.santiago@chsli.org

Principal Investigator:

Richard A Shlofmitz, MD

More Information

Sponsor

St. Francis Hospital, New York

Last update posted

Feb 5, 2016

Last verified

Feb, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Francis Hospital, New York on 2016-02-05.