Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study

This study has been completed.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT00905671
First received: May 15, 2009
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions that contain lipid cores, but are not calcified or fibrotic and are located in proximity to side branches, are associated with side branch compromise as a result of plaque shift during angioplasty and stenting. Plaque characteristics will be detected by intravascular near infrared spectroscopy (NIRS).


Condition Intervention Phase
Angina Pectoris
Angina, Unstable
Atherosclerosis
Coronary Artery Disease
Device: LipiScan Coronary Imaging Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of Lipid Core Plaque Shift at Sites of Native Coronary Artery Bifurcation

Resource links provided by NLM:


Further study details as provided by InfraReDx:

Primary Outcome Measures:
  • Angiographic evidence of plaque shift. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCP+ Bifurcation Lesion
Bifurcating lesions that are positive for lipid core plaque, as detected by LipiScan Coronary Imaging, prior to angioplasty.
Device: LipiScan Coronary Imaging Catheter
Intravascular near infrared spectroscopic imaging of the coronary artery with a fiberoptic catheter.
Experimental: LCP- Bifurcation Lesion
Bifurcating lesions that are not positive for lipid core plaque, as detected by LipiScan Coronary Imaging, prior to angioplasty.
Device: LipiScan Coronary Imaging Catheter
Intravascular near infrared spectroscopic imaging of the coronary artery with a fiberoptic catheter.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be >=40yrs
  • Subject must provide written informed consent.
  • Subject must be diagnosed with stable or unstable angina pectoris, or documented silent ischemia
  • Subject must be scheduled for elective or non-emergent percutaneous coronary intervention
  • Angiographic evidence of a bifurcation lesion with the following characteristics:

    • Native coronary artery
    • De novo coronary stenosis at the bifurcation site
    • Bifurcation Medina class 1,1,0 or 1,0,0 or 0,1,0
    • Main vessel stenosis >50%, with the stenotic lesion in close proximity (≤2mm) to the side branch ostium, by visual estimate.
    • Side branch diameter ≥ 2.0mm by visual estimate.
    • Side branch without significant stenosis (<30% stenosis)
    • LipiScan catheter optical tip must cross lesion without the need for pre-dilatation

Exclusion Criteria:

  • Subject is pregnant or nursing
  • Renal insufficiency (Creatinine >2.0mg/dL)
  • Left ventricular ejection fraction <25% by visual estimate.
  • Known allergy to contrast media that cannot be medically managed.
  • Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
  • Any condition or symptom that in the investigator's opinion may adversely alter the risk profile of this study for the subject.
  • Target lesion is dilated prior to first LipiScan imaging.
  • Subject experiences procedural complication that precludes clear post angioplasty imaging of the target lesion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905671

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
InfraReDx
Columbia University
Investigators
Principal Investigator: Giora Weisz, MD Columbia University
  More Information

Publications:
Reimers B, Colombo A, Tobis J. Bifurcation Lesions. In: Colombo A, Tobis J, eds. Techniques in Coronary Artery Stenting. London 2000, pp 171-204.
Safian RD, Freed MS, Grines C, Freed M. ed., The Manual of Interventional Cardiology. pp 221-236.
Louvard Y, Lefevre T, Cherukupalli R. Favorable Effect of the Jailed Wire Technique When Stenting Bifurcation Lesions. Am J Cardiol 2003:6 (abstr, suppl).

Responsible Party: InfraReDx
ClinicalTrials.gov Identifier: NCT00905671     History of Changes
Other Study ID Numbers: 0102
Study First Received: May 15, 2009
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by InfraReDx:
Lipid Core Plaque
LCP
Bifurcation
Stenosis
Lesion
Angioplasty

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 22, 2014