- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060175
Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne
January 7, 2015 updated by: Yonsei University
We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES).
The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients ≥ 20 years old
- Patients in the treatment of subjects with all-comer who are to undergo PCI
Exclusion Criteria:
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 CILOTAX arm
Cilotax drug-eluting stents implantation
|
|
Active Comparator: 2 DESyne arm
DESyne drug-eluting stents implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stent coverage
Time Frame: up to 3 months after stent implantation
|
The percentage of stent uncoverage measured by OCT
|
up to 3 months after stent implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
February 7, 2014
First Submitted That Met QC Criteria
February 9, 2014
First Posted (Estimate)
February 11, 2014
Study Record Updates
Last Update Posted (Estimate)
January 9, 2015
Last Update Submitted That Met QC Criteria
January 7, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 1-2013-0076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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