- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932995
DXR Stent for Vascular Healing and Thrombus Formation: OCT Study
October 18, 2016 updated by: Sang-Wook Kim, Chung-Ang University
Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study
The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sang-Wook Kim, MD, PhD
- Phone Number: +82-6299-1260
- Email: swivus@gmail.com
Study Locations
-
-
-
Daejeon, Korea, Republic of, 35365
- Konyang University Hospital
-
Contact:
- Jangho Bae
- Phone Number: +82-42-600-9409
- Email: janghobae@yahoo.co.kr
-
Principal Investigator:
- Jangho Bae, MD, PhD
-
Jeju, Korea, Republic of
- Jeju National University Hospital
-
Seoul, Korea, Republic of, 06973
- Chung-Ang University Hospital
-
Seoul, Korea, Republic of
- Korea University Guro Hospital
-
Principal Investigator:
- JIN WON KIM, MD, PhD
-
Contact:
- JIN WON KIM
- Phone Number: +82-2-2626-1899
- Email: kjwmm@korea.ac.kr
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Seoul, Korea, Republic of, 02447
- Kyunghee University Medical Center
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Ulsan, Korea, Republic of, 44033
- Ulsan University Hospital
-
Contact:
- Eun Seok Shin
- Phone Number: +82-52-250-8838
- Email: sesim1989@gmail.com
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Principal Investigator:
- Eun Seok Shin, MD, PhD
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who undergo coronary artery intervention with DXR stent
Description
Inclusion Criteria:
Patient
- Age >=19 years
- Clinically indicated to invasive coronary angiography
- Patient capable and willing of giving written informed consent
Angiographic
- coronary artery disease confined to native coronary artery
- >50% diameter stenosis by invasive coronary angiography
- reference diameter 2.5-4.0mm, lesion length ≤30 mm
Exclusion Criteria:
Patient
- Inability to provide written informed consent
- Serious comorbidity which may affect the trial by decision of investigators
- Prior CABG to target vessel
- Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%
- Prior ST elevation myocardial infarction within 72 hours from the procedure
- Hemodynamic or electrical instability including shock
- Serious coronary artery spasm, unrelated to catheter
- Pregnancy or possible pregnant status
- Allergy to iodinated contrast agent
- Serum creatinine >=1.7 mg/dL or creatinine clearance <= 30 ml/min
- ST elevation myocardial infarction
Angiographic (OCT)
- Left main disease
- Severely calcified lesion
- Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision
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
Cohorts and Interventions
Group / Cohort |
---|
DXR stent group
Patients who undergo coronary intervention with DXR stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stent strut coverage (Incidence of uncovered strut)
Time Frame: 6 month
|
Coronary angiography with OCT follow up
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stent malapposition
Time Frame: 6 month
|
Coronary angiography with OCT follow up
|
6 month
|
Stent thrombosis
Time Frame: 6 month
|
Coronary angiography with OCT follow up
|
6 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)
Time Frame: 1 year
|
Clinical outcome follow up
|
1 year
|
long term major cardiovascular event major adverse cardiovascular event (all-cause death, stroke, unexpected revascularization)
Time Frame: 3 year
|
Clinical outcome follow up
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sang-Wook Kim, MD, PhD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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
October 1, 2016
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 12, 2016
First Posted (Estimate)
October 14, 2016
Study Record Updates
Last Update Posted (Estimate)
October 19, 2016
Last Update Submitted That Met QC Criteria
October 18, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2015201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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