Computer Prediction of Restenosis Following Peripheral Angioplasty

NCT01202344 | Terminated

• 1 other identifier: 08-0335-BE
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Logistic Regression Analysis

  6 months

Study Arms (2)

Restenosis

OTHER

Patients who have restinosis immediately following angioplasty.

Other: Additional x-ray images

No Restenosis

OTHER

Patients who do not have restinosis immediately following angioplasty.

Other: Additional x-ray images

Interventions

Additional x-ray images OTHER

Approximately 3 additional x-ray images following angioplasty (within 1 hour)

No Restenosis; Restenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• previous revascularization of the target lesion;
• subject undergoing chemotherapy.

Sponsors & Collaborators

• Dheeraj Rajan: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (10)

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MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dheeraj Rajan, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 15, 2010
• Study Start: September 1, 2010
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CA (1)