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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060175
Enrollment
0
Registered
2014-02-11
Start date
2014-02-28
Completion date
2014-08-31
Last updated
2015-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI

Keywords

Optical coherence tomography, Drug-eluting stent, Strut coverage

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.

Interventions

DEVICECilotax drug-eluting stents implantation
DEVICEDESyne drug-eluting stents implantation

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Stent coverageup to 3 months after stent implantationThe percentage of stent uncoverage measured by OCT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026