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

NCT00905671 | Completed Phase 4

• 1 other identifier: 0102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Angina Pectoris; Angina, Unstable; Atherosclerosis; Coronary Artery Disease

Keywords

Lipid Core Plaque; LCP; Bifurcation; Stenosis; Lesion; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Angiographic evidence of plaque shift.

  Day 0

Study Arms (2)

LCP+ Bifurcation Lesion

EXPERIMENTAL

Bifurcating lesions that are positive for lipid core plaque, as detected by LipiScan Coronary Imaging, prior to angioplasty.

Device: LipiScan Coronary Imaging Catheter

LCP- Bifurcation Lesion

EXPERIMENTAL

Bifurcating lesions that are not positive for lipid core plaque, as detected by LipiScan Coronary Imaging, prior to angioplasty.

Device: LipiScan Coronary Imaging Catheter

Interventions

LipiScan Coronary Imaging Catheter DEVICE

Intravascular near infrared spectroscopic imaging of the coronary artery with a fiberoptic catheter.

LCP+ Bifurcation Lesion; LCP- Bifurcation Lesion

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Infraredx: lead
• Columbia University: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (17)

• Reimers B, Colombo A, Tobis J. Bifurcation Lesions. In: Colombo A, Tobis J, eds. Techniques in Coronary Artery Stenting. London 2000, pp 171-204.

  BACKGROUND

• Louvard Y, Lefevre T, Morice MC. Percutaneous coronary intervention for bifurcation coronary disease. Heart. 2004 Jun;90(6):713-22. doi: 10.1136/hrt.2002.007682. No abstract available.

  PMID: 15145893 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23.

  PMID: 14981005 BACKGROUND

• Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. doi: 10.1016/j.jacc.2005.05.080. Epub 2005 Sep 28.

  PMID: 16226167 BACKGROUND

• Louvard Y, Lefevre T. Bifurcation lesion stenting. In Colombo A, Stankovic G, eds. Problem oriented approaches in interventional cardiology. Informa Healthcare 2007.

  BACKGROUND

• 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. doi: 10.1016/0735-1097(93)90589-s.

  PMID: 8227832 BACKGROUND

• 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. doi: 10.1016/0002-9149(94)90549-5.

  PMID: 7977091 BACKGROUND

• Pan M, Medina A, Suarez de Lezo J, Romero M, Melian F, Pavlovic D, Hernandez 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. doi: 10.1016/0002-8703(95)90264-3.

  PMID: 7872167 BACKGROUND

• 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. doi: 10.1016/s0002-9149(97)00591-2.

  PMID: 9352966 BACKGROUND

• 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. doi: 10.1002/ccd.1287.

  PMID: 11747152 BACKGROUND

• 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. doi: 10.1016/s0002-9149(02)02295-6.

  PMID: 12008166 BACKGROUND

• 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. doi: 10.1002/ccd.1810270307.

  PMID: 1423574 BACKGROUND

• 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. doi: 10.1002/ccd.1810220102.

  PMID: 1995167 BACKGROUND

• 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. doi: 10.1161/01.cir.102.1.7.

  PMID: 10880407 BACKGROUND

• 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. doi: 10.1016/s0002-9149(00)01161-9.

  PMID: 11074201 BACKGROUND

• Safian RD, Freed MS, Grines C, Freed M. ed., The Manual of Interventional Cardiology. pp 221-236.

  BACKGROUND

• Louvard Y, Lefevre T, Cherukupalli R. Favorable Effect of the Jailed Wire Technique When Stenting Bifurcation Lesions. Am J Cardiol 2003:6 (abstr, suppl).

  BACKGROUND

MeSH Terms

Conditions

Angina Pectoris; Angina, Unstable; Atherosclerosis; Coronary Artery Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Pathological Conditions, Anatomical

Study Officials

• Giora Weisz, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 20, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

US (1)