Optical Imaging Measurement of Intravascular Solution Efficacy Trial

NCT01743872 | Completed Results DMC

• 1 other identifier: OPTIMISE
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with intravascular Optical Coherence Tomography (iOCT) to improve image quality in human coronary arteries as well as carotid arteries. The current debate in the literature for iOCT medium is between iodinated contrast and dextran and CO2 may offer a superior method of iOCT imaging during lower extremity occlusive disease interventions. The investigators hypothesize that the CO2 medium injection during iOCT data acquisition is feasible and will produce at least the same quality of imaging as that obtained with contrast or dextran without causing the problems of volume overload and renal toxicity seen with the two latter mediums. Primary Outcomes Measured

• Quality: Cumulative number of clear image frame (CIF) through the entire 54mm length segment.
• Quantitative: Calculations of the area and diameter of each segment will be measured to determine if index of refraction has any effect between the three mediums to be tested. The investigators expect to find little difference between all three iOCT mediums and hope to conclude that CO2 offers a superior side effect profile for iOCT imaging in the lower extremity arterial system.

Conditions

Peripheral Artery Disease

Keywords

Optical Coherence Tomography; Contrast; Dextran; Carbon Dioxide; Imaging; Catheter; Lower Extremity Artery

Outcome Measures

Primary Outcomes (1)

• Quality of Images

  The metric of image quality was the clear imaging field (CIF), which was defined as a cross section in which ≥270° of the vessel wall architecture was visualized. This has been used previously to quantify adequacy of clearance in OCT image comparison. Two independent observers, blinded to the flush medium used, analyzed all OCT frames in each pullback sequence. Any disagreement \>10% was resolved with a consensus re-evaluation at a later time point by the same reviewers. Each individual cross section was assigned a designation of quality or insufficient quality; thus, a quality image proportion was generated for each run by taking the mean of each observer's determinations

  1 month

Secondary Outcomes (1)

• Superficial Femoral Artery Plaque Composition by Flush Medium

  1 month

Study Arms (1)

iOCT

EXPERIMENTAL

Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014" wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed

Procedure: Contrast Injection; Procedure: Dextran Injection; Procedure: CO2 Injection; Procedure: Heparinized Normal Saline Injection

Interventions

Contrast Injection PROCEDURE

Media #1: IV Contrast (Omnipaque 350) will be continuously injected at a rate range of 2.5-6ml/s for a maximum of 5 seconds. (Volume range of 12.5- 30ml) Intervention protocol will be followed per Cross-Reference Intervention.

iOCT

Dextran Injection PROCEDURE

Media #2: Dextran 40 Solution will be continuously injected at a rate range of 2.5-6ml/s for a maximum of 5 seconds. (Volume range of 12.5- 30ml. Intervention protocol will be followed per Cross-Reference Intervention.

iOCT

CO2 Injection PROCEDURE

Media #3: Carbon Dioxide (CO2) will be injected with large volume hand injection syringe as per the usual protocol. This be done with particular attention to avoid air in the closed system. In addition to supine, there is also an option that the patient's distal limb may be elevated to improve the flow of CO2 during injection. The surgeon will also wait at least 2 minutes between each CO2 injection to allow any potentially trapped CO2 to dissolve. A range of 20-60 ml will be used with each hand injection based on the data from the initial 5-10 pilot patients. Intervention protocol will be followed per Cross-Reference Intervention.

iOCT

Heparinized Normal Saline Injection PROCEDURE

Media #4: Heparinized Normal Saline (Heparin NS) will be hand injected using 20 mL (2 U/mL) in antegrade fashion.

iOCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years
• English speaking
• Scheduled to undergo an infrainguinal angiogram and/or endovascular procedure as determined by a vascular surgery specialist
• Superficial Femoral Artery diseased segment

You may not qualify if:

• Acute or Chronic Renal insufficiency with Cr \>1.5
• Chronic obstructive pulmonary disease
• Congestive heart failure (American Heart Association C lass III or IV)
• Acute limb ischemia, defined by a significant change in symptoms (one category on the Rutherford scale within the previous 14 days)
• Concurrent oral anticoagulant therapy that cannot be safely withheld

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (20)

• Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.

  PMID: 11560536 BACKGROUND

• Chamie D, Wang Z, Bezerra H, Rollins AM, Costa MA. Optical Coherence Tomography and Fibrous Cap Characterization. Curr Cardiovasc Imaging Rep. 2011 Aug;4(4):276-283. doi: 10.1007/s12410-011-9090-8. Epub 2011 May 12.

  PMID: 21949565 BACKGROUND

• Jones MR, Attizzani GF, Given CA 2nd, Brooks WH, Costa MA, Bezerra HG. Intravascular frequency-domain optical coherence tomography assessment of atherosclerosis and stent-vessel interactions in human carotid arteries. AJNR Am J Neuroradiol. 2012 Sep;33(8):1494-501. doi: 10.3174/ajnr.A3016. Epub 2012 Mar 15.

  PMID: 22422179 BACKGROUND

• Stefano GT, Mehanna E, Parikh SA. Imaging a spiral dissection of the superficial femoral artery in high resolution with optical coherence tomography-seeing is believing. Catheter Cardiovasc Interv. 2013 Feb;81(3):568-72. doi: 10.1002/ccd.24292. Epub 2012 Apr 17.

  PMID: 22511464 BACKGROUND

• Ozaki Y, Kitabata H, Tsujioka H, Hosokawa S, Kashiwagi M, Ishibashi K, Komukai K, Tanimoto T, Ino Y, Takarada S, Kubo T, Kimura K, Tanaka A, Hirata K, Mizukoshi M, Imanishi T, Akasaka T. Comparison of contrast media and low-molecular-weight dextran for frequency-domain optical coherence tomography. Circ J. 2012;76(4):922-7. doi: 10.1253/circj.cj-11-1122. Epub 2012 Feb 3.

  PMID: 22301848 BACKGROUND

• Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak RM. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations. J Vasc Surg. 2009 Jul;50(1):54-60. doi: 10.1016/j.jvs.2009.01.035. Epub 2009 May 28.

  PMID: 19481407 BACKGROUND

• Li QX, Fu QQ, Shi SW, Wang YF, Xie JJ, Yu X, Cheng X, Liao YH. Relationship between plasma inflammatory markers and plaque fibrous cap thickness determined by intravascular optical coherence tomography. Heart. 2010 Feb;96(3):196-201. doi: 10.1136/hrt.2009.175455. Epub 2009 Oct 28.

  PMID: 19875365 BACKGROUND

• Kataiwa H, Tanaka A, Kitabata H, Matsumoto H, Kashiwagi M, Kuroi A, Ikejima H, Tsujioka H, Okochi K, Tanimoto T, Yamano T, Takarada S, Nakamura N, Kubo T, Mizukoshi M, Hirata K, Imanishi T, Akasaka T. Head to head comparison between the conventional balloon occlusion method and the non-occlusion method for optical coherence tomography. Int J Cardiol. 2011 Jan 21;146(2):186-90. doi: 10.1016/j.ijcard.2009.06.059. Epub 2009 Aug 7.

  PMID: 19664829 BACKGROUND

• Brezinski M, Saunders K, Jesser C, Li X, Fujimoto J. Index matching to improve optical coherence tomography imaging through blood. Circulation. 2001 Apr 17;103(15):1999-2003. doi: 10.1161/01.cir.103.15.1999.

  PMID: 11306530 BACKGROUND

• Xu X, Yu L, Chen Z. Optical clearing of flowing blood using dextrans with spectral domain optical coherence tomography. J Biomed Opt. 2008 Mar-Apr;13(2):021107. doi: 10.1117/1.2909673.

  PMID: 18465956 BACKGROUND

• Hoang KC, Edris A, Su J, Mukai DS, Mahon S, Petrov AD, Kern M, Ashan C, Chen Z, Tromberg BJ, Narula J, Brenner M. Use of an oxygen-carrying blood substitute to improve intravascular optical coherence tomography imaging. J Biomed Opt. 2009 May-Jun;14(3):034028. doi: 10.1117/1.3153895.

  PMID: 19566321 BACKGROUND

• Hawkins IF, Cho KJ, Caridi JG. Carbon dioxide in angiography to reduce the risk of contrast-induced nephropathy. Radiol Clin North Am. 2009 Sep;47(5):813-25, v-vi. doi: 10.1016/j.rcl.2009.07.002.

  PMID: 19744596 BACKGROUND

• Kerns SR, Hawkins IF Jr. Carbon dioxide digital subtraction angiography: expanding applications and technical evolution. AJR Am J Roentgenol. 1995 Mar;164(3):735-41. doi: 10.2214/ajr.164.3.7863904.

  PMID: 7863904 BACKGROUND

• Moos JM, Ham SW, Han SM, Lew WK, Hua HT, Hood DB, Rowe VL, Weaver FA. Safety of carbon dioxide digital subtraction angiography. Arch Surg. 2011 Dec;146(12):1428-32. doi: 10.1001/archsurg.2011.195.

  PMID: 22288088 BACKGROUND

• Weaver FA, Pentecost MJ, Yellin AE, Davis S, Finck E, Teitelbaum G. Clinical applications of carbon dioxide/digital subtraction arteriography. J Vasc Surg. 1991 Feb;13(2):266-72; discussion 272-3.

  PMID: 1899274 BACKGROUND

• Hawkins IF, Caridi JG. Carbon dioxide (CO2) digital subtraction angiography: 26-year experience at the University of Florida. Eur Radiol. 1998;8(3):391-402. doi: 10.1007/s003300050400.

  PMID: 9510571 BACKGROUND

• Groeneveld AB, Navickis RJ, Wilkes MM. Update on the comparative safety of colloids: a systematic review of clinical studies. Ann Surg. 2011 Mar;253(3):470-83. doi: 10.1097/SLA.0b013e318202ff00.

  PMID: 21217516 BACKGROUND

• Kubo T, Nakamura N, Matsuo Y, Okumoto Y, Wu X, Choi SY, Komukai K, Tanimoto T, Ino Y, Kitabata H, Kimura K, Mizukoshi M, Imanishi T, Akagi H, Yamamoto T, Akasaka T. Virtual histology intravascular ultrasound compared with optical coherence tomography for identification of thin-cap fibroatheroma. Int Heart J. 2011;52(3):175-9. doi: 10.1536/ihj.52.175.

  PMID: 21646741 BACKGROUND

• Karnabatidis D, Katsanos K, Paraskevopoulos I, Diamantopoulos A, Spiliopoulos S, Siablis D. Frequency-domain intravascular optical coherence tomography of the femoropopliteal artery. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1172-81. doi: 10.1007/s00270-010-0092-8. Epub 2010 Dec 30.

  PMID: 21191586 BACKGROUND

• Kendrick DE, Allemang MT, Gosling AF, Nagavalli A, Kim AH, Nishino S, Parikh SA, Bezerra HG, Kashyap VS. Dextran or Saline Can Replace Contrast for Intravascular Optical Coherence Tomography in Lower Extremity Arteries. J Endovasc Ther. 2016 Oct;23(5):723-30. doi: 10.1177/1526602816657392. Epub 2016 Jul 5.

  PMID: 27385151 DERIVED

Related Links

• Harrington Heart and Vascular Institute

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Contrast Media; Dextrans

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Limitations and Caveats

This was a single-center case series that was powered to detect only large differences in image quality. Subtle differences between the 3 liquid media may not have been appreciated despite analysis of over 10,000 individual frames.

Results Point of Contact

• Title: Dr. Vikram S. Kashyap
• Organization: Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center

vikram.kashyap@uhhospitals.org

216-844-1631

Study Officials

• Vikram S Kashyap, MD

  UH Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: December 6, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Locations

US (1)