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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 20, 2009
Last Update Posted: September 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Columbia University
Information provided by (Responsible Party):
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: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Lipid Core Plaque Shift at Sites of Native Coronary Artery Bifurcation

Further study details as provided by InfraReDx:

Primary Outcome Measures:
  • Angiographic evidence of plaque shift. [ Time Frame: Day 0 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905671

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

Reimers B, Colombo A, Tobis J. Bifurcation Lesions. In: Colombo A, Tobis J, eds. Techniques in Coronary Artery Stenting. London 2000, pp 171-204.
Louvard Y, Lefèvre T, Morice MC. Percutaneous coronary intervention for bifurcation coronary disease. Heart. 2004 Jun;90(6):713-22. Review.
Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. Epub 2004 Feb 23.
Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. Epub 2005 Sep 28. Review.
Louvard Y, Lefevre T. Bifurcation lesion stenting. In Colombo A, Stankovic G, eds. Problem oriented approaches in interventional cardiology. Informa Healthcare 2007.
Fischman DL, Savage MP, Leon MB, Schatz RA, Ellis S, Cleman MW, Hirshfeld JW, Teirstein P, Bailey S, Walker CM, et al. Fate of lesion-related side branches after coronary artery stenting. J Am Coll Cardiol. 1993 Nov 15;22(6):1641-6.
Mazur W, Grinstead WC, Hakim AH, Dabaghi SF, Abukhalil JM, Ali NM, Joseph J, French BA, Raizner AE. Fate of side branches after intracoronary implantation of the Gianturco-Roubin flex-stent for acute or threatened closure after percutaneous transluminal coronary angioplasty. Am J Cardiol. 1994 Dec 15;74(12):1207-10.
Pan M, Medina A, Suárez de Lezo J, Romero M, Melián F, Pavlovic D, Hernández E, Segura J, Marrero J, Torres F, et al. Follow-up patency of side branches covered by intracoronary Palmaz-Schatz stent. Am Heart J. 1995 Mar;129(3):436-40.
Aliabadi D, Tilli FV, Bowers TR, Benzuly KH, Safian RD, Goldstein JA, Grines CL, O'Neill WW. Incidence and angiographic predictors of side branch occlusion following high-pressure intracoronary stenting. Am J Cardiol. 1997 Oct 15;80(8):994-7.
Bhargava B, Waksman R, Lansky AJ, Kornowski R, Mehran R, Leon MB. Clinical outcomes of compromised side branch (stent jail) after coronary stenting with the NIR stent. Catheter Cardiovasc Interv. 2001 Nov;54(3):295-300.
Almeda FQ, Nathan S, Calvin JE, Parrillo JE, Klein LW. Frequency of abrupt vessel closure and side branch occlusion after percutaneous coronary intervention in a 6.5-year period (1994 to 2000) at a single medical center. Am J Cardiol. 2002 May 15;89(10):1151-5.
Ciampricotti R, el Gamal M, van Gelder B, Bonnier J, Taverne R. Coronary angioplasty of bifurcational lesions without protection of large side branches. Cathet Cardiovasc Diagn. 1992 Nov;27(3):191-6.
Weinstein JS, Baim DS, Sipperly ME, McCabe CH, Lorell BH. Salvage of branch vessels during bifurcation lesion angioplasty: acute and long-term follow-up. Cathet Cardiovasc Diagn. 1991 Jan;22(1):1-6.
Ahmed JM, Mintz GS, Weissman NJ, Lansky AJ, Pichard AD, Satler LF, Kent KM. Mechanism of lumen enlargement during intracoronary stent implantation: an intravascular ultrasound study. Circulation. 2000 Jul 4;102(1):7-10.
Maehara A, Takagi A, Okura H, Hassan AH, Bonneau HN, Honda Y, Yock PG, Fitzgerald PJ. Longitudinal plaque redistribution during stent expansion. Am J Cardiol. 2000 Nov 15;86(10):1069-72.
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
First Submitted: May 15, 2009
First Posted: May 20, 2009
Last Update Posted: September 4, 2014
Last Verified: September 2014

Keywords provided by InfraReDx:
Lipid Core Plaque

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

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