Intravascular Ultrasound (IVUS) Angiography Co-registration Clinical Trial
During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients undergoing routine coronary angioplasty Exclusion Criteria: - Cardiogenic shock - Acute myocardial infarction |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hillel Yaffe Medical Center | Hadera |
| Lead Sponsor | Collaborator |
|---|---|
| Hillel Yaffe Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Accuracy of Co-Registration of IVUS and Coronary Angiography | For determination of the accuracy of the co-registration feature, and the accuracy and precision of the length measurements, a flexible phantom was used in order to simulate an artery and enable simulation of the cardiac motion. The sample size for testing the co-registration algorithm was 108 samples (each sample was defined as a landmark). The resultant mean of the absolute distance accuracy was 0.995 mm with a standard deviation of 0.809 mm. The statistical validation in phantoms, resulted in an accuracy of 1.12 mm, meeting the original specification. | One month | No |