Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease

NCT02364778 | Completed Results

• 1 other identifier: GCO 14-1777
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.

Conditions

Coronary Artery Disease

Keywords

CAD

Outcome Measures

Primary Outcomes (1)

• MLD SB Diameter

  Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)

  day 1

Secondary Outcomes (3)

• SB Angle

  day 1

• SB Ostial Involvement

  day 1

• Diameter Stenosis (DS)

  day 1

Study Arms (1)

Provisional stenting strategy

Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned

You may qualify if:

• Over 18 years of age presenting with stable coronary artery disease.
• Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited

You may not qualify if:

• Patient with lesion involving side branch ( \>70 %) by angiogram and need pre-dilation.
• Patients with ostial left main artery lesions or ostial right coronary artery lesions
• Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Known allergy to acetylsalicylic acid or clopidogrel.
• Planned surgery within 12 months.
• History of bleeding diathesis
• Major surgery within 15 days
• Life expectancy \< 12 months.
• Patients with kidney dysfunction (CrCl\<30)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Kini AS, Vengrenyuk Y, Pena J, Yoshimura T, Panwar SR, Motoyama S, Kezbor S, Hasan CM, Palkhiwala S, Kovacic JC, Moreno P, Baber U, Mehran R, Narula J, Sharma SK. Plaque morphology predictors of side branch occlusion after provisional stenting in coronary bifurcation lesion: Results of optical coherence tomography bifurcation study (ORBID). Catheter Cardiovasc Interv. 2017 Feb 1;89(2):259-268. doi: 10.1002/ccd.26524. Epub 2016 Mar 31.

  PMID: 27029714 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

Small number of cases. Results represent a hypothesis-generating pilot study rather than a definitive result.

Results Point of Contact

• Title: Dr. Annapoorna Kini
• Organization: Icahn School Of Medicine at Mount Sinai

annapoorna.kini@mountsinai.org

Study Officials

• Annapoorna Kini, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 7, 2016
• Results First Posted: July 7, 2016

Record last verified: 2016-05

Locations

US (1)