COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02060175
Recruitment Status : Withdrawn (Because of the problem with Cilotax stent permission)
First Posted : February 11, 2014
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI Device: Cilotax drug-eluting stents implantation Device: DESyne drug-eluting stents implantation Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: 1 CILOTAX arm
Cilotax drug-eluting stents implantation
Device: Cilotax drug-eluting stents implantation
Active Comparator: 2 DESyne arm
DESyne drug-eluting stents implantation
Device: DESyne drug-eluting stents implantation

Primary Outcome Measures :
  1. Stent coverage [ Time Frame: up to 3 months after stent implantation ]
    The percentage of stent uncoverage measured by OCT

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Layout table for additonal information
Responsible Party: Yonsei University Identifier: NCT02060175    
Other Study ID Numbers: 1-2013-0076
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by Yonsei University:
Optical coherence tomography, Drug-eluting stent, Strut coverage