Coronary Artery DiseaseNCT02932995
DXR Stent for Vascular Healing and Thrombus Formation: OCT Study
An observational study of Coronary Artery Disease and Coronary Stent Occlusion, run by Chung-Ang University at 6 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Stent Occlusion
- How many people
- 60 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Oct 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo coronary artery intervention with DXR stent
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Konyang University Hospital
Daejeon, 35365
Jangho Bae, +82-42-600-9409, janghobae@yahoo.co.kr
Jangho Bae, MD, PhD
Jeju National University Hospital
Jeju City
KyungHee University Medical Center
Seoul, 02447
Chung-Ang University Hospital
Seoul, 06973
Korea University Guro Hospital
Seoul
JIN WON KIM, +82-2-2626-1899, kjwmm@korea.ac.kr
JIN WON KIM, MD, PhD
Ulsan university hospital
Ulsan, 44033
Eun Seok Shin, +82-52-250-8838, sesim1989@gmail.com
Eun Seok Shin, MD, PhD
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease, Coronary Stent Occlusion
- Keywords
- Optical Coherence Tomography, Drug-Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DXR stent group | Patients who undergo coronary intervention with DXR stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent strut coverage (Incidence of uncovered strut)
Coronary angiography with OCT follow up
Measured: 6 month
Secondary outcomes (2)
Stent malapposition
Coronary angiography with OCT follow up
Measured: 6 month
Stent thrombosis
Coronary angiography with OCT follow up
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Collaborators
- Konyang University Hospital, Kyunghee University Medical Center, Korea University Guro Hospital, Ulsan University Hospital, Jeju National University Hospital
- Responsible party
- Principal investigator, Sang-Wook Kim, Chung-Ang University
- Investigators
- Sang-Wook Kim, MD, PhD, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932995
- Sponsor's protocol ID
- C2015201
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DUAL Drug-eluting Stent ( DXR Stent) for Vascular Healing and Thrombus Formation : an Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT02932995
- Acronym / sponsor ID
- C2015201
- Conditions
- Coronary Artery Disease, Coronary Stent Occlusion
- Keywords
- Optical Coherence Tomography, Drug-Eluting Stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Collaborators
- Konyang University Hospital, Kyunghee University Medical Center, Korea University Guro Hospital, Ulsan University Hospital, Jeju National University Hospital
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DXR stent group | – | –Patients who undergo coronary intervention with DXR stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo coronary artery intervention with DXR stent
Key inclusion criteria (8 listed)
- Patient
- Angiographic
Key exclusion criteria (16 listed)
- Patient
- Angiographic (OCT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stent strut coverage (Incidence of uncovered strut)
Time frame: 6 month
Coronary angiography with OCT follow up
2 secondary outcomes
Stent malapposition
Time frame: 6 month
Stent thrombosis
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Wook Kim, MD, PhD principal investigator
Chung-Ang University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stent Occlusion, run by Chung-Ang University at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Wook Kim, MD, PhD (+82-6299-1260, swivus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent strut coverage (Incidence of uncovered strut) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.