Clinical Trials -Optical Coherence Tomography News

Articles in category: Clinical Trials

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1. Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigation
  
  Explore ClinicalTrials.gov Jun 25 2014 Cardiology , Clinical Trials
  
  Objective of this First in Man study is to assess feasibility and safety of Qvanteq's bioactive coronary stent for treatment of stable coronary artery disease patients with de novo coronary artery stenosis in native vessels. The proprietary surface of Qvanteq's bioactive coronary stent improves the in-growth behavior of the stent in the treated vessel. In-vivo animal studies revealed fast in-growth (similar to BMS), which however is not resulting in excessive tissue overgrowth as observed in BMS but rather has an efficacy profile similar to drug-eluting stent (DES), meaning suppression of tissue overgrowth. This should reduce the risk of ...
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  Mentions: Patrick W. Serruys Erasmus University
2. Does Optical Coherence Tomography Optimize Results of Stenting? (DOCTORS) Rationale and Study Design
  
  Explore ScienceDirect May 26 2014 Cardiology , Clinical Trials
  
  Background To date, no randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of coronary angioplasty for non-ST elevation acute coronary syndromes (NSTE-ACS). Methods DOCTORS is a randomized, prospective, multicentre, open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for NSTE-ACS. Patients (n = 250) will be randomized to undergo OCT-guided angioplasty (use of OCT to optimise procedural result, including change to strategy with the possibility of additional interventions); or angioplasty under fluoroscopy alone. The primary endpoint is the functional result of the angioplasty procedure as ...
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3. OCT in Rare Chorioretinal Diseases
  
  Explore Home - ClinicalTrials.gov May 20 2014 Ophthalmology , Clinical Trials , Velocimetry
  
  This study will evaluate the total blood flow in the retina and choroid (structures in the back of the eye) by Doppler optical coherence tomography (OCT) and OCT angiography. Angiography is mapping of the blood vessels. The purpose of measuring blood flow in the retina and choroid is to 1.) determine if rare diseases in these structures causes a change in blood flow compared to healthy eyes and 2.) find out if areas of changed blood flow line up with areas of damage that appear on conventional testing.
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  Mentions: David Huang Oregon Health & Science University Center for Ophthalmic Optics and Lasers
4. Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel
  
  Explore ClinicalTrials.gov May 14 2014 Cardiology , Clinical Trials
  
  A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).
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5. Optical Coherence Tomography (OCT) in Hypertension & Chronic Kidney Disease (CKD)
  
  Explore ClinicalTrials.gov Apr 29 2014 Urology , Clinical Trials
  
  Patients with high blood pressure (hypertension) and chronic kidney disease are at an increased risk of developing heart disease and strokes. Part of this risk is due to changes in the structure and function of the blood vessels throughout the body. It is thought that reducing high blood pressure and treating chronic kidney disease improves the structure and function of blood vessels but information on this is limited. Optical coherence tomography (OCT) is a method of looking at the blood vessels at the back of the eye. It is a simple, quick and non-invasive test that you may have previously ...
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6. Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial
  
  Explore Trials Apr 25 2014 Cardiology , Clinical Trials
  
  Background The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions. Methods Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1 ...
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7. Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty (OCTOPUS-2)
  
  Explore ClinicalTrials.gov Apr 19 2014 Cardiology , Clinical Trials
  
  We aimed to evaluate feasibility and the 6-month angiographic and OCT results of FFR - guided use of paclitaxel-eluting balloons (Sequent Please™, B Braun) with provisional bare metal stenting for elective PCI of de novo coronary lesions.
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8. Optical Coherence Tomography in Staging Patients With Upper Tract Urothelial Cancer
  
  Explore ClinicalTrials.gov Apr 7 2014 Oncology , Urology , Clinical Trials
  
  This clinical trial studies how well optical coherence tomography works in staging patients with upper-tract urothelial carcinomas. Staging describes the severity of a person's cancer based on the size and/or extent (reach) of the original (primary) tumor and whether or not cancer has spread in the body. It also helps the doctor plan the appropriate treatment. Optical coherence tomography is a procedure that uses infrared light waves to give three-dimensional pictures of structures inside tissues and organs. The pictures are made by a computer linked to the light source. Optical coherence tomography may be effective in staging patients ...
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  Mentions: National Cancer Institute
9. Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting
  
  Explore ClinicalTrials.gov Mar 25 2014 Cardiology , Clinical Trials
  
  Optical coherence tomography (OCT) has been recently studied for evaluation of coronary stenting. Because of high resolutions, several reports have shown that OCT is appropriate for evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage and the characterization of neointimal tissue can be accurately evaluated. Furthermore, OCT-defined coverage of a stent strut was proposed to be related with clinical safety in drug-eluting stents-treated patients. Therefore, we will evaluate the appropriateness of currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc) based on ...
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  Mentions: Yonsei University Myeong-Ki Hong
10. Comparison of Biodegradable Stents: Orsiro and BioMatrix
  
  Explore ClinicalTrials.gov Mar 9 2014 Cardiology , Clinical Trials
  
  The use of a biodegradable polymer has the potential to reduce the sustained inflammatory response of the arterial wall, facilitating re-endothelialization and minimizing the risk of thrombus formation and late restenosis. In the study, we are going to two biodegradable polymer stents, Orsiro and BioMatrix, especially regarding the stent strut coverage by optical coherence tomography at 3 months after stent implantation. The primary objective of this study is to test the hypothesis that Orsiro is non-inferior to Biomatrix in terms of stent strut coverage by optical coherence tomography at 3 months. The secondary endpoint is clinical outcomes up to 1 ...
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  Mentions: Yonsei University
11. Non-Invasive Evaluation of Transplant Kidney Using OCT
  
  Explore ClinicalTrials.gov Mar 6 2014 Urology , Clinical Trials
  
  Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function as a type of "optical biopsy", providing non-invasive cross-sectional images of tissue architectural morphology in situ and in real-time. This proposal will demonstrate that OCT has the ability to provide novel and valuable histopathological information regarding donor kidneys that can be used to predict post-transplant renal function. These investigations will result in a major breakthrough in increasing the number of healthy kidneys available for transplantation by making the most efficient use of available donor kidneys, eliminating the possible use of bad donor kidneys, providing an accurate measure ...
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  Mentions: Georgetown University
12. Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
  
  Explore ClinicalTrials.gov Feb 12 2014 Cardiology , Clinical Trials
  
  Coronary artery stenting has evolved as an effective treatment for angina and involves stretching up narrowings within the heart arteries using a balloon (coronary angioplasty) before implanting a small metal scaffold (stent) to splint the artery open. It is imperative that stents are fully expanded when they are deployed. If not, then patients are exposed to the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and 70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart attacks. Arguably ...
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13. Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne
  
  Explore ClinicalTrials.gov Feb 7 2014 Cardiology , Clinical Trials
  
  We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.
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  Mentions: Yonsei University
14. Optical Coherence Tomography as a Biomarker in Clinical Trials for Ophthalmology and Neurology (Book Chapter)
  
  Explore Home - Springer Jan 23 2014 Ophthalmology , Clinical Trials , Textbooks
  
  In the past, clinical trials in neuro-ophthalmology have focused upon functional endpoints including Snellen visual acuity and visual field testing, both of which may have significant test/retest variability because of their dependence upon subject alertness and cognitive function. The introduction of optical coherence tomography (OCT) into the practice of clinical ophthalmology has now extended into clinical trials in both ophthalmology and neurology. Recent advances in the resolution and reproducibility of spectral-domain OCT have now produced algorithms that measure the structural integrity of the optic nerve and retina. OCT is in vivo histopathology and the qualitative and quantitative metrics of ...
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15. Imaging Lens Deposits in Exfoliation Syndrome
  
  Explore ClinicalTrials.gov Jan 21 2014 Ophthalmology , Clinical Trials
  
  The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma ...
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  Mentions: Duke University
16. Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
  
  Explore ClinicalTrials.gov Dec 18 2013 Ophthalmology , Clinical Trials
  
  The purpose of this study is to evaluate choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women
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17. Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case
  
  Explore ClinicalTrials.gov Dec 12 2013 Cardiology , Clinical Trials
  
  To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- ...
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  Mentions: Toshiro Shinke Kobe University Graduate School of Medicine
18. Multicenter Randomized Comparison of Early Vascular Responses Between Multicenter Randomized Comparison of Early Vascular Responses Between Everolimus-eluting Cobalt-CHromium Stent ANd Identically DeSigned Bare-Metal Stent in Patients With Acute Myocardia
  
  Explore ClinicalTrials.gov Dec 12 2013 Cardiology , Clinical Trials
  
  To evaluate early vessel response between current standard drug-eluting stent and bare-metal stent in acute myocardial infarction (AMI) patients by optical coherence tomography (OCT).
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  Mentions: Iwate Medical University
19. Optical Coherence Tomography (OCT) Normative Data Collection Study
  
  Explore ClinicalTrials.gov Dec 11 2013 Ophthalmology , Clinical Trials
  
  This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device.
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  Mentions: Heidelberg Engineering New York Eye and Ear Infirmary Jeffrey M. Liebmann
20. OCT in Retinal Vein Occlusions
  
  Explore ClinicalTrials.gov Nov 19 2013 Ophthalmology , Clinical Trials
  
  Retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. Of these conditions, retinal vein occlusions are the most common. Vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula). OCT is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structures in real time. It is similar to ultrasound imaging, except that OCT measures the intensity of reflected light rather than sound waves. The purpose of this study is to see if non-invasive OCT technology can changes due ...
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  Mentions: David Huang Oregon Health & Science University
21. OCT Reference Database
  
  Explore ClinicalTrials.gov Nov 11 2013 Ophthalmology , Clinical Trials
  
  Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
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  Mentions: Topcon Medical Systems Topcon 3D OCT-2000
22. Transform OCT TRiple Assessment of Neointima Stent FOrmation to Reabsorbable polyMer With Optical Coherence Tomography
  
  Explore ClinicalTrials.gov Oct 24 2013 Cardiology , Clinical Trials
  
  First prospective randomized controlled study to evaluate in an 'all-comers' population with coronary artery disease whether treatment with a novel everolimus eluting stent (EES) with a biodegradable polymer is superior to a durable polymer zotarolimus eluting stent (ZES), with respect to the long term vascular response to treatment These data are important to ascertain the superiority of a new generation DES with bioabsorbable polymer coating to reduce the long term development of in-stent neoatherosclerosis.
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  Mentions: Giulio Guagliumi
23. Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT
  
  Explore ClinicalTrials.gov Oct 18 2013 Ophthalmology , Clinical Trials
  
  The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).
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  Mentions: University of Leipzig
24. Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
  
  Explore ClinicalTrials.gov Oct 8 2013 Cardiology , Clinical Trials
  
  The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) [Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)] at 6 weeks post implantation. Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ...
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  Mentions: UT Southwestern Medical Center
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