Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCIPhase 4NCT02060175
Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne
A Phase 4 study testing Cilotax drug-eluting stents implantation and DESyne drug-eluting stents implantation in people with Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI, run by Yonsei University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI
- What is being tested?
- Cilotax drug-eluting stents implantation and DESyne drug-eluting stents implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2014
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 20 years old
- Patients in the treatment of subjects with all-comer who are to undergo PCI
Who cannot join
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
About this study
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.
- Being tested
- Cilotax drug-eluting stents implantation, DESyne drug-eluting stents implantation
- Keywords
- Optical coherence tomography, Drug-eluting stent, Strut coverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilotax drug-eluting stents implantationDevice
DESyne drug-eluting stents implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 CILOTAX arm | Experimental | Cilotax drug-eluting stents implantation Receives: Device: Cilotax drug-eluting stents implantation |
| 2 DESyne arm | Active comparator | DESyne drug-eluting stents implantation Receives: Device: DESyne drug-eluting stents implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent coverage
The percentage of stent uncoverage measured by OCT
Measured: up to 3 months after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Because of the problem with Cilotax stent permission
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCIStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060175
- Sponsor's protocol ID
- 1-2013-0076
- Status last verified
- Jan 2015
- First submitted
- 7 Feb 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne
- ClinicalTrials.gov ID
- NCT02060175
- Acronym / sponsor ID
- 1-2013-0076
- Keywords
- Optical coherence tomography, Drug-eluting stent, Strut coverage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of the problem with Cilotax stent permission
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Feb 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 CILOTAX arm | Experimental | Device: Cilotax drug-eluting stents implantationCilotax drug-eluting stents implantation |
| 2 DESyne arm | Active comparator | Device: DESyne drug-eluting stents implantationDESyne drug-eluting stents implantation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 20 years old
- Patients in the treatment of subjects with all-comer who are to undergo PCI
Key exclusion criteria (2 listed)
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilotax drug-eluting stents implantation | Device | 1 CILOTAX arm |
| DESyne drug-eluting stents implantation | Device | 2 DESyne arm |
Primary outcome
Stent coverage
Time frame: up to 3 months after stent implantation
The percentage of stent uncoverage measured by OCT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilotax drug-eluting stents implantation and DESyne drug-eluting stents implantation in people with Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI, run by Yonsei University.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent coverage (time frame: up to 3 months after stent implantation). 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 9 Jan 2015.