Computer Prediction of Restenosis Following Peripheral Angioplasty
NCT ID: NCT01202344
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2010-09-30
2024-12-03
Brief Summary
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Detailed Description
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Logistic regression analysis will be performed using NCSS statistical software to identify which explanatory variable(s), selected from the simulation results, can be used to predict binary restenosis, the categorical dependent variable.
For each subject, binary restenosis will be determined by comparing the CT-scan images obtained 1 hour post-intervention to those obtained at the 6 month follow-up study. The CT-scan images will be segmented and a mesh of the target vessel will be reconstructed as described in objective 1. The lumen area will be measured in every cross-section of the mesh perpendicular to the vessel centerline, with 2 mm steps between cross-sections. The minimum lumen diameter will be calculated from the minimum lumen area. If the minimum lumen diameter at follow-up is less than 50% of the minimum lumen diameter post-intervention, then the binary restenosis is positive. Otherwise it is negative.
Objective 1: Evaluate the accuracy of computer predictions of artery dilatation and stent implantation from CT-scan images. This information is hypothesized to be indicative of the accuracy of other quantities predicted by computer simulation of angioplasty, such as those used as independent variables in objective 2.
Objective 2: Establish a regression model with 80% sensitivity and 80% specificity for predicting binary restenosis based on one or several injury parameters in patients undergoing angioplasty. The candidate injury parameters are:
* endothelium denudation (in % of total endothelium area)
* descriptors of the magnitude and spatial distribution of stretch ratio in the arterial wall
* descriptors of the magnitude and spatial distribution of intramural stress in the arterial wall All injury parameters are predicted by computer simulation of angioplasty.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Restenosis
Patients who have restinosis immediately following angioplasty.
Additional x-ray images
Approximately 3 additional x-ray images following angioplasty (within 1 hour)
No Restenosis
Patients who do not have restinosis immediately following angioplasty.
Additional x-ray images
Approximately 3 additional x-ray images following angioplasty (within 1 hour)
Interventions
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Additional x-ray images
Approximately 3 additional x-ray images following angioplasty (within 1 hour)
Eligibility Criteria
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Inclusion Criteria
* age more than 18 years;
* informed consent signed by the subject;
* target lesion in native artery;
* baseline lumen diameter greater than 4 mm.
Exclusion Criteria
* subject undergoing chemotherapy.
18 Years
ALL
No
Sponsors
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Dheeraj Rajan
OTHER
Responsible Party
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Dheeraj Rajan
Associate Professor
Principal Investigators
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Dheeraj Rajan, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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References
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Hoffmann R, Mintz GS, Mehran R, Kent KM, Pichard AD, Satler LF, Leon MB. Tissue proliferation within and surrounding Palmaz-Schatz stents is dependent on the aggressiveness of stent implantation technique. Am J Cardiol. 1999 Apr 15;83(8):1170-4. doi: 10.1016/s0002-9149(99)00053-3.
Koyama J, Owa M, Sakurai S, Shimada H, Hikita H, Higashikata T, Ikeda S. Relation between vascular morphologic changes during stent implantation and the magnitude of in-stent neointimal hyperplasia. Am J Cardiol. 2000 Oct 1;86(7):753-8. doi: 10.1016/s0002-9149(00)01075-4.
Syeda B, Wexberg P, Gyongyosi M, Denk S, Beran G, Kiss K, Sperker W, Glogar D. Effects of radial stretch on target lesion revascularization after percutaneous coronary intervention: an intravascular ultrasound study. Can J Cardiol. 2003 May;19(6):691-7.
Schwartz RS, Huber KC, Murphy JG, Edwards WD, Camrud AR, Vlietstra RE, Holmes DR. Restenosis and the proportional neointimal response to coronary artery injury: results in a porcine model. J Am Coll Cardiol. 1992 Feb;19(2):267-74. doi: 10.1016/0735-1097(92)90476-4.
Rogers C, Tseng DY, Squire JC, Edelman ER. Balloon-artery interactions during stent placement: a finite element analysis approach to pressure, compliance, and stent design as contributors to vascular injury. Circ Res. 1999 Mar 5;84(4):378-83. doi: 10.1161/01.res.84.4.378.
Capron L, Bruneval P. Influence of applied stress on mitotic response of arteries to injury with a balloon catheter: quantitative study in rat thoracic aorta. Cardiovasc Res. 1989 Nov;23(11):941-8. doi: 10.1093/cvr/23.11.941.
Olson NE, Chao S, Lindner V, Reidy MA. Intimal smooth muscle cell proliferation after balloon catheter injury. The role of basic fibroblast growth factor. Am J Pathol. 1992 May;140(5):1017-23.
Jamal A, Bendeck M, Langille BL. Structural changes and recovery of function after arterial injury. Arterioscler Thromb. 1992 Mar;12(3):307-17. doi: 10.1161/01.atv.12.3.307.
Doornekamp FN, Borst C, Post MJ. Endothelial cell recoverage and intimal hyperplasia after endothelium removal with or without smooth muscle cell necrosis in the rabbit carotid artery. J Vasc Res. 1996 Mar-Apr;33(2):146-55. doi: 10.1159/000159143.
Nugent HM, Rogers C, Edelman ER. Endothelial implants inhibit intimal hyperplasia after porcine angioplasty. Circ Res. 1999 Mar 5;84(4):384-91. doi: 10.1161/01.res.84.4.384.
Other Identifiers
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08-0335-BE
Identifier Type: -
Identifier Source: org_study_id