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NCT01816347 Clinical Trial

Evaluation of Pre-deployment Device-to-artery Relative Axial Motion in Coronary Catheterizations

Cardiovascular Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01816347
Other study ID # HYMC-61-11
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 20, 2013
Last updated March 21, 2013
Start date April 2013
Est. completion date August 2013

Study information
Verified date March 2013
Source Hillel Yaffe Medical Center
Contact Aharon Frimerman, MD
Phone 972-523-543264
Email afrimer@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The cyclic movement of the heart and the coronary arteries induces relative axial movement between the artery and a pre-deployed intra-luminal stent which may cause malpositioning. Using a new imaging algorithm to indicate the position of a stent in patients undergoing percutaneous coronary intervention (PCI), the investigators will measure the pre-deployment relative, intra-luminal stent axial movement in the different coronary arteries to facilitate the precise deployment site.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 250
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients undergoing routine PCI

Exclusion Criteria:

- Unstable patients

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Routine PCI

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relative axial movement of predeployed stent One month No
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