MedDataX Logo

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

NCT ID: NCT02060175

Last Updated: 2015-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of Stent Malapposition and Neointimal Coverage on Optical coHerence Tomography at Post-procedure and 3 Months After Platinum Chromium Alloy Of the Element™ Stent Implantation

NCT01581515

Coronary Artery Disease
UNKNOWN PHASE4

Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)

NCT01962740

Drug Eluting Stents (DES) Percutaneous Coronary Intervention (PCI) Uncovered and Malapposed Stent Struts +1 more
TERMINATED NA

Optical Coherence Tomography to Evaluate Paclitaxel-Eluting Balloons and Everolimus-Eluting Coronary Stents

NCT01056744

Stents Neointimal Proliferation
COMPLETED PHASE4

ComparisiOn of Neointimal coVerage betwEen ZES and EES Using OCT at 3 Months

NCT01091740

Coronary Artery Disease
COMPLETED PHASE4

Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents

NCT01502904

Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 CILOTAX arm

Cilotax drug-eluting stents implantation

Group Type EXPERIMENTAL

Cilotax drug-eluting stents implantation

Intervention Type DEVICE

2 DESyne arm

DESyne drug-eluting stents implantation

Group Type ACTIVE_COMPARATOR

DESyne drug-eluting stents implantation

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cilotax drug-eluting stents implantation

Intervention Type DEVICE

DESyne drug-eluting stents implantation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-2013-0076

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of TCFA on Neointimal Coverage After PCI at 9 Months Follow-up
NCT02384837 COMPLETED
Late Stent Strut Apposition and Coverage After Drug-Eluting Stent Implantation by OCT in Patients With AMI
NCT02770651 UNKNOWN
Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns
NCT01024179 TERMINATED NA
Optical Coherence TomOgraphy Assessment of the Drug-Eluting Stent
NCT01012583 UNKNOWN
The Optical Coherence Tomography Drug Eluting Stent Investigation
NCT00776204 COMPLETED NA
Comparison of Neointimal Coverage Between Zotarolimus Eluting Stent and Everolimus Eluting Stent
NCT00894062 COMPLETED PHASE4
Optical Coherence Tomography in Long Lesions
NCT01133925 UNKNOWN PHASE4
ORSIRO Stents Versus Xience PRIME Stents Assessed by Optical Coherence Tomography
NCT01594736 COMPLETED PHASE4
OCT Based Edge and In-stent Vascular Response After Cordimax Stent in patIents With NSTE-ACS
NCT02868203 UNKNOWN PHASE4
Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for DES Surface COVERage by OCT
NCT01021930 TERMINATED NA
Optical Coherence Tomography for Drug Eluting Stent Safety
NCT00693030 UNKNOWN PHASE4
Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
NCT00704145 COMPLETED PHASE4
Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
NCT01097434 COMPLETED PHASE4
Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation
NCT04465669 COMPLETED NA
The DECISION-CTO Extended 10 Y Follow-up
NCT06908499 NOT_YET_RECRUITING
Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study
NCT01856374 COMPLETED PHASE4
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
NCT02060357 COMPLETED NA
Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS
NCT01543373 COMPLETED NA
Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent: A Optical Coherent Tomography Study
NCT01925027 UNKNOWN PHASE4
DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold
NCT03074305 WITHDRAWN NA
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
NCT05544864 RECRUITING NA
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)
NCT01078051 TERMINATED PHASE4
StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
NCT03401216 UNKNOWN NA
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
NCT01875835 TERMINATED NA
OPtimal stEnt Deployment stRategy oF Contemporary sTents - Registry to Evaluate Percutaneous Coronary Intervention Using Bioresorbable Scaffolds With Thinner-strut Construction and Guidance by intracOronary Imaging to REduce Scaffold Failure
NCT06919562 NOT_YET_RECRUITING