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

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ClinicalTrials.gov Identifier: NCT02060175
Recruitment Status : Withdrawn (Because of the problem with Cilotax stent permission)
First Posted : February 11, 2014
Last Update Posted : January 9, 2015
Sponsor:
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

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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



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

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

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02060175     History of Changes
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