Peripheral Artery DiseaseOPTIMISENCT01743872
Optical Imaging Measurement of Intravascular Solution Efficacy Trial
A study testing Contrast Injection, Dextran Injection and CO2 Injection in people with Peripheral Artery Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Contrast Injection, Dextran Injection and CO2 Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read more
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.
Read the detailed description
Peripheral artery disease (PAD) affects anywhere from 8-12 Million people in the United States. Many of these people go on to develop claudication, rest pain, and tissue loss. During the workup for these disease states many imaging modalities are conducted including Pulse Volume Recording, Duplex Ultrasound, Angiography, and IVUS, but an emerging catheter based imaging has been developed that may supplement the current modalities used.
Intravascular optical coherence tomography (iOCT) is based on near-infrared light system. The light reflects off plaque and other objects within vessels and the signals are processed into a series of axial images (A-scans) at different positions along the artery to generate a two-dimensional dataset (B-scans). These images are created at an extremely fine resolution of 10-15 μm, which has allowed iOCT to be used in many research settings including PAD and coronary artery disease. OCT has been approved for clinical use in the coronary territory by the FDA in May 2010. Since then many centers have been using iOCT in the daily clinical practice. However, it's still not widely in the clinical management of patients with PAD. There is hope that the high resolution capabilities of iOCT may help before and after an intervention to predict outcomes or correct errors in stent deployment.
The iOCT procedure for lower extremity PAD is fairly straightforward. An introducer is placed into the femoral artery. After which a wire is placed past the lesion of interest and the iOCT catheter is inserted. The catheter is then attached to an automated pullback device. Next an optical medium is needed to displace the erythrocytes. Due to the high resolution of the iOCT this is necessary for a cleaner image to analyze. At the time of injection of the optical medium a sensor triggers the catheter to be withdrawn (distal to proximal) at anywhere from 10-25 mm/sec. The images are captured and processed and arterial plaque can be characterized.
The greatest strength of the iOCT catheter is its high resolution images but the problem is that the imaging signal is substantially attenuated by blood. In order to remedy this complication techniques such as proximal balloon occlusion and continuous infusion of a fluid have been used to acquire improved iOCT images. In the continuous infusion methods, different mediums have been injected such as contrast, dextran, and even an oxygen-carrying substitute in hopes of improving decreasing the attenuation by blood.
In order the overcome the attenuation of red blood cells during iOCT imaging, we are proposing a novel approach involving CO2 injection to clear the erythrocytes. Currently CO2 is used as medium for digital subtraction angiography in patients with renal insufficiency and was first used in humans by Hawkins in 1982. The other alternative for angiography, iodinated contrast medium, is nephrotoxic and thus is avoided in these patients for fear of exacerbating the patient's acute or chronic problem. Another group where CO2 angiography is employed is history of a contrast allergy. Although this technique is usually used under these circumstances, Kerns et al reports conducting CO2 angiography in as high as 20% of their patients with abdominal and lower extremity studies.
In addition to the benefits of patients with allergies and renal insufficiency, CO2 is extremely safe in a variety of arterial and venous applications. It is 20 times as soluble as room air and is expired through the lungs in a first-pass-type effect. The current contraindication to CO2 digital subtraction angiography is that the cerebral arterial circulation should never be exposed to CO2 because of possible neurotoxicity. Relative contraindications include use in the presence of a large arteriovenous shunt, with nitrous oxide anesthesia, and used cautiously in patients with chronic obstructive pulmonary disease.
Dextran has been used in the past in the critical care setting of human as a volume expander with the rare side effects of anaphylaxis and nephrotoxicity. It has also been used in human coronary arteries with iOCT as a blood displacement medium. Finally it has been used with iOCT in a proximal occlusion model. The main complaint in the final study was a burning sensation that lasted < 10s.
Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Contrast Injection, Dextran Injection, CO2 Injection, Heparinized Normal Saline Injection
- Keywords
- Optical Coherence Tomography, Contrast, Dextran, Carbon Dioxide, Imaging, Catheter, Lower Extremity Artery
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast InjectionProcedure or surgery
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.
Dextran InjectionProcedure or surgery
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.
CO2 InjectionProcedure or surgery
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.
Heparinized Normal Saline InjectionProcedure or surgery
Media #4: Heparinized Normal Saline (Heparin NS) will be hand injected using 20 mL (2 U/mL) in antegrade fashion.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Contrast Injection; Procedure: Dextran Injection; Procedure: CO2 Injection; Procedure: Heparinized Normal Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
Superficial Femoral Artery Plaque Composition by Flush Medium
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikram S Kashyap, MD, Principal investigator, UH Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743872
- Sponsor's protocol ID
- OPTIMISE
- Acronym
- OPTIMISE
- Status last verified
- Aug 2022
- First submitted
- 26 Sep 2012
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 11560536Chamie 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.
PubMed 21949565Jones 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.
PubMed 22422179Stefano 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.
PubMed 22511464Ozaki 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.
PubMed 22301848Goodney 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.
PubMed 19481407Li 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.
PubMed 19875365Kataiwa 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.
PubMed 19664829Brezinski 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.
PubMed 11306530Xu 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.
PubMed 18465956Hoang 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.
PubMed 19566321Hawkins 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.
PubMed 19744596Kerns 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.
PubMed 7863904Moos 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.
PubMed 22288088Weaver 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.
PubMed 1899274
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Imaging Measurement of Intravascular Solution Efficacy Trial
- ClinicalTrials.gov ID
- NCT01743872
- Acronym / sponsor ID
- OPTIMISE / OPTIMISE
- Conditions
- Peripheral Artery Disease
- Keywords
- Optical Coherence Tomography, Contrast, Dextran, Carbon Dioxide, Imaging, Catheter, Lower Extremity Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral artery disease (PAD) affects anywhere from 8-12 Million people in the United States. Many of these people go on to develop claudication, rest pain, and tissue loss. During the workup for these disease states many imaging modalities are conducted including Pulse Volume Recording, Duplex Ultrasound, Angiography, and IVUS, but an emerging catheter based imaging has been developed that may supplement the current modalities used.
Intravascular optical coherence tomography (iOCT) is based on near-infrared light system. The light reflects off plaque and other objects within vessels and the signals are processed into a series of axial images (A-scans) at different positions along the artery to generate a two-dimensional dataset (B-scans). These images are created at an extremely fine resolution of 10-15 μm, which has allowed iOCT to be used in many research settings including PAD and coronary artery disease. OCT has been approved for clinical use in the coronary territory by the FDA in May 2010. Since then many centers have been using iOCT in the daily clinical practice. However, it's still not widely in the clinical management of patients with PAD. There is hope that the high resolution capabilities of iOCT may help before and after an intervention to predict outcomes or correct errors in stent deployment.
The iOCT procedure for lower extremity PAD is fairly straightforward. An introducer is placed into the femoral artery. After which a wire is placed past the lesion of interest and the iOCT catheter is inserted. The catheter is then attached to an automated pullback device. Next an optical medium is needed to displace the erythrocytes. Due to the high resolution of the iOCT this is necessary for a cleaner image to analyze. At the time of injection of the optical medium a sensor triggers the catheter to be withdrawn (distal to proximal) at anywhere from 10-25 mm/sec. The images are captured and processed and arterial plaque can be characterized.
The greatest strength of the iOCT catheter is its high resolution images but the problem is that the imaging signal is substantially attenuated by blood. In order to remedy this complication techniques such as proximal balloon occlusion and continuous infusion of a fluid have been used to acquire improved iOCT images. In the continuous infusion methods, different mediums have been injected such as contrast, dextran, and even an oxygen-carrying substitute in hopes of improving decreasing the attenuation by blood.
In order the overcome the attenuation of red blood cells during iOCT imaging, we are proposing a novel approach involving CO2 injection to clear the erythrocytes. Currently CO2 is used as medium for digital subtraction angiography in patients with renal insufficiency and was first used in humans by Hawkins in 1982. The other alternative for angiography, iodinated contrast medium, is nephrotoxic and thus is avoided in these patients for fear of exacerbating the patient's acute or chronic problem. Another group where CO2 angiography is employed is history of a contrast allergy. Although this technique is usually used under these circumstances, Kerns et al reports conducting CO2 angiography in as high as 20% of their patients with abdominal and lower extremity studies.
In addition to the benefits of patients with allergies and renal insufficiency, CO2 is extremely safe in a variety of arterial and venous applications. It is 20 times as soluble as room air and is expired through the lungs in a first-pass-type effect. The current contraindication to CO2 digital subtraction angiography is that the cerebral arterial circulation should never be exposed to CO2 because of possible neurotoxicity. Relative contraindications include use in the presence of a large arteriovenous shunt, with nitrous oxide anesthesia, and used cautiously in patients with chronic obstructive pulmonary disease.
Dextran has been used in the past in the critical care setting of human as a volume expander with the rare side effects of anaphylaxis and nephrotoxicity. It has also been used in human coronary arteries with iOCT as a blood displacement medium. Finally it has been used with iOCT in a proximal occlusion model. The main complaint in the final study was a burning sensation that lasted < 10s.
Iodinated contrast is the current gold standard for infrainguinal angiography imaging in patients without renal insufficiency and has also been used with 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iOCT | Experimental | Procedure: Contrast Injection, Procedure: Dextran Injection, Procedure: CO2 Injection, Procedure: Heparinized Normal Saline InjectionArterial 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast InjectionMedia #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. | Procedure or surgery | iOCT |
| Dextran InjectionMedia #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. | Procedure or surgery | iOCT |
| CO2 InjectionMedia #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. | Procedure or surgery | iOCT |
| Heparinized Normal Saline InjectionMedia #4: Heparinized Normal Saline (Heparin NS) will be hand injected using 20 mL (2 U/mL) in antegrade fashion. | Procedure or surgery | iOCT |
Primary outcome
Quality of Images
Time frame: 1 month
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 secondary outcome
Superficial Femoral Artery Plaque Composition by Flush Medium
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11560536Hirsch 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.
- Background: PubMed 21949565Chamie 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.
- Background: PubMed 22422179Jones 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.
- Background: PubMed 22511464Stefano 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.
- Background: PubMed 22301848Ozaki 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.
- Background: PubMed 19481407Goodney 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.
- Background: PubMed 19875365Li 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.
- Background: PubMed 19664829Kataiwa 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.
- Background: PubMed 11306530Brezinski 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.
- Background: PubMed 18465956Xu 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.
- Background: PubMed 19566321Hoang 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.
- Background: PubMed 19744596Hawkins 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.
- Harrington Heart and Vascular InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikram S Kashyap, MD principal investigator
UH Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Injection, Dextran Injection and CO2 Injection in people with Peripheral Artery Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Images (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743872, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.