Computer Prediction of Restenosis Following Peripheral Angioplasty

Peripheral Angioplasty Clinical Trial

Official title:

Computer Prediction of Restenosis Following Peripheral Angioplasty

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01202344
• Other study ID #: 08-0335-BE
• Status: Suspended
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2032

Study information

• Verified date: November 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop a computer program that might be able to accurately assess the risk of artery re-narrowing following angioplasty or stenting based on computer images. After angioplasty (a procedure to re-open narrowed or blocked blood vessels) the patients will have extra images taken in order to assess the results of the procedure; which will then be used to see whether or not these images can help predict outcomes such as the patient having to come back to the hospital to have the procedure done again.

Description:

The study involves medical imaging of patients undergoing an angioplasty intervention in a peripheral artery. It is similar to an observational study, except that additional imaging is performed which is above the standard-of-care. Some risks may be associated with the additional imaging due to a small increase in radiation exposure and intravenous contrast administration. No investigational drug or device will be tested in this study. No control group will be used.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled for percutaneous dilation of a peripheral artery;

• 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:

• previous revascularization of the target lesion;

• subject undergoing chemotherapy.

Related Conditions & MeSH terms

• Peripheral Angioplasty

Intervention

Other:
• Additional x-ray images
Approximately 3 additional x-ray images following angioplasty (within 1 hour)

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dheeraj Rajan

Country where clinical trial is conducted

Canada, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simulation Accuracy	From the pre-intervention CT-scans, the target artery, calcium and lumen will be segmented, meshed and used to simulate the angioplasty steps. Simulation accuracy will be evaluated by comparing geometrical descriptors of the artery and lumen size and shape calculated in the simulation to those measured on the post-intervention CT scan images.	less than 6 hours after the procedure
Secondary	Logistic Regression Analysis	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.; 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.	6 months