Peripheral AngioplastyNCT01202344
Computer Prediction of Restenosis Following Peripheral Angioplasty
A study testing Additional x-ray images in people with Peripheral Angioplasty, run by Dheeraj Rajan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Angioplasty
- What is being tested?
- Additional x-ray images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- previous revascularization of the target lesion;
- subject undergoing chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Peripheral Angioplasty
- Being tested
- Additional x-ray images
- Keywords
- Angioplasty, Stenosis, Restenosis, Elastic Recoil, cheduled for percutaneous dilation of a peripheral artery, Target lesion in native artery, Baseline lumen diameter greater than 4 mm
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional x-ray imagesOther
Approximately 3 additional x-ray images following angioplasty (within 1 hour)
| Study group | Role | What they receive |
|---|---|---|
| Restenosis | Other | Patients who have restinosis immediately following angioplasty. Receives: Other: Additional x-ray images |
| No Restenosis | Other | Patients who do not have restinosis immediately following angioplasty. Receives: Other: Additional x-ray images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: less than 6 hours after the procedure
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startSep 2010
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Peripheral AngioplastyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dheeraj Rajan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dheeraj Rajan, University Health Network, Toronto
- Investigators
- Dheeraj Rajan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202344
- Sponsor's protocol ID
- 08-0335-BE
- Status last verified
- Dec 2024
- First submitted
- 10 Sep 2010
- Last updated
- 6 Dec 2024
- Results posted
- No
Publications
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.
PubMed 10215278Koyama 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.
PubMed 11018195Syeda 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.
PubMed 12772020Schwartz 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.
PubMed 1732351Rogers 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.
PubMed 10066671Capron 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.
PubMed 2611802Olson 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.
PubMed 1580326Jamal 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.
PubMed 1547190Doornekamp 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.
PubMed 8630348Nugent 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.
PubMed 10066672
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Prediction of Restenosis Following Peripheral Angioplasty
- ClinicalTrials.gov ID
- NCT01202344
- Acronym / sponsor ID
- 08-0335-BE
- Conditions
- Peripheral Angioplasty
- Keywords
- Angioplasty, Stenosis, Restenosis, Elastic Recoil, cheduled for percutaneous dilation of a peripheral artery, Target lesion in native artery, Baseline lumen diameter greater than 4 mm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dheeraj RajanUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restenosis | Other | Other: Additional x-ray imagesPatients who have restinosis immediately following angioplasty. |
| No Restenosis | Other | Other: Additional x-ray imagesPatients who do not have restinosis immediately following angioplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- previous revascularization of the target lesion;
- subject undergoing chemotherapy.
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 |
|---|---|---|
| Additional x-ray imagesApproximately 3 additional x-ray images following angioplasty (within 1 hour) | Other | No Restenosis, Restenosis |
Primary outcome
Simulation Accuracy
Time frame: less than 6 hours after the procedure
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.
1 secondary outcome
Logistic Regression Analysis
Time frame: 6 months
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 10215278Hoffmann 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.
- Background: PubMed 11018195Koyama 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.
- Background: PubMed 12772020Syeda 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.
- Background: PubMed 1732351Schwartz 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.
- Background: PubMed 10066671Rogers 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.
- Background: PubMed 2611802Capron 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.
- Background: PubMed 1580326Olson 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.
- Background: PubMed 1547190Jamal 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.
- Background: PubMed 8630348Doornekamp 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.
- Background: PubMed 10066672Nugent 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.
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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.
Dheeraj Rajan, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional x-ray images in people with Peripheral Angioplasty, run by Dheeraj Rajan at 1 site in Canada.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Dec 2024. 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 Canada. 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?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
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?
Simulation Accuracy (time frame: less than 6 hours after the procedure). 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 NCT01202344, which also lists 10 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 6 Dec 2024.