Chronic Kidney DiseasesPhase 4OKAYNCT06475625
Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease
A Phase 4 study testing Percutaneous coronary intervention and Orsiro™ or Orsiro_Mission™ stent in people with Chronic Kidney Diseases and Coronary Artery Disease, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention and Orsiro™ or Orsiro_Mission™ stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,113 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2019to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 19 years of age or older
- Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
Who cannot join
- Patient with a life expectancy of less than one year
- Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time
- Cardiogenic shock
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daejeon St. Mary's Hospital , The Catholic University of Korea
Daejeon
About this study
Official title: Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Undergoing Percutaneous Coronay Intervention : A Multicenter, Prospective All-comers Registry
Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR < 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.
- Conditions
- Chronic Kidney Diseases, Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention, Orsiro™ or Orsiro_Mission™ stent
- Keywords
- Chronic Kidney Diseases, Coronary Artery Disease, Orsiro stent
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Percutaneous coronary intervention
Orsiro™ or Orsiro_Mission™ stentDevice
Percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
| Study group | Role | What they receive |
|---|---|---|
| Normal or mild renal dysfunction | Experimental | eGFR ≥ 60 ml·min - 1·1.73㎡ Receives: Procedure: Percutaneous coronary intervention; Device: Orsiro™ or Orsiro_Mission™ stent |
| Moderate renal dysfunction | Experimental | 30≤ eGFR< 60 ml·min - 1·1.73㎡ Receives: Procedure: Percutaneous coronary intervention; Device: Orsiro™ or Orsiro_Mission™ stent |
| Severe renal dysfunction | Experimental | eGFR < 30 ml·min -1·1.73㎡ Receives: Procedure: Percutaneous coronary intervention; Device: Orsiro™ or Orsiro_Mission™ stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target-lesion failure (TLF)
Number of participants with Target-lesion failure (TLF), defined as composite of cardiac death, target vessel-related myocardial infarction (TVMI) and ischemia-driven target-lesion revascularization (TLR) at 1 year
Measured: Within one year after the intervention
Secondary outcomes (9)
Number of participants with all cause death
Measured: Within three years after the intervention
Number of participants with cardiac death
Measured: Within three years after the intervention
Number of participants with myocardial infarction
periprocedural or spontaneous
Measured: Within three years after the intervention
Number of participants with composite of death or myocardial infarction
Measured: Within three years after the intervention
Number of participants with composite of cardiac death or myocardial infarction
Measured: Within three years after the intervention
Number of participants with target-vessel revascularization
Measured: Within three years after the intervention
Number of participants with target-lesion revascularization
Measured: Within three years after the intervention
Number of participants with stent thrombosis
Stent thrombosis appropriate for Academic Research Consortium criteria
Measured: Within three years after the intervention
Number of participants with target-vessel failure
composite of composite of death, nonfatal myocardial infarction and ischemia-drive target-vessel revascularization (TVR)
Measured: Within three years after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start22 Oct 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahn-Won Park, The Catholic University of Korea
- Investigators
- Mahn-Won Park, Study chair, Daejeon St. Mary's Hospital , The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475625
- Sponsor's protocol ID
- DC190OEDI0069
- Acronym
- OKAY
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Orsiro™ Stent in Patient With Chronic Kidney Disease Undergoing Percutaneous Coronay Intervention : A Multicenter, Prospective All-comers Registry
- ClinicalTrials.gov ID
- NCT06475625
- Acronym / sponsor ID
- OKAY / DC190OEDI0069
- Conditions
- Chronic Kidney Diseases, Coronary Artery Disease
- Keywords
- Chronic Kidney Diseases, Coronary Artery Disease, Orsiro stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,113 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- 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.
Orsiro™ or Orsiro_Mission™ stents have the biodegradable polymer and the thinnest stent strut (60㎛) in commercially available stents, which could minimize chronic inflammation and incomplete endothelialization. In several prior studies, ultrathin strut sirolimus-eluting stent (Orsiro®) showed better outcomes in terms of target lesion failure or target lesion revascularization compared to other contemporary stents. Chronic kidney disease (CKD) is known to be associated with adverse cardiovascular outcome including restenosis or stent thrombosis following percutaneous coronary interventin (PCI), because the patients with CKD have more complex coronary lesion characteristics, severe calcification, and diffuse plaque of the coronary artery. However, there is a paucity of data regarding clinical efficacy of Orsiro® in CKD population. Therefore, this study aims to investigate the differences in clinical outcomes according to renal function in patients undergoing PCI with Orsiro™ or Orsiro_Mission™ stents. After patients will be divided into three groups according to the renal function; normal or mild renal dysfunction (eGFR ≥ 60 ml·min - 1·1.73㎡), moderate renal dysfunction ( 30≤ eGFR< 60 ml·min - 1·1.73㎡), and severe renal dysfunction (eGFR < 30 ml·min -1·1.73㎡), the clinical outcome will be investigated among groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal or mild renal dysfunction | Experimental | Procedure: Percutaneous coronary intervention, Device: Orsiro™ or Orsiro_Mission™ stenteGFR ≥ 60 ml·min - 1·1.73㎡ |
| Moderate renal dysfunction | Experimental | Procedure: Percutaneous coronary intervention, Device: Orsiro™ or Orsiro_Mission™ stent30≤ eGFR< 60 ml·min - 1·1.73㎡ |
| Severe renal dysfunction | Experimental | Procedure: Percutaneous coronary intervention, Device: Orsiro™ or Orsiro_Mission™ stenteGFR < 30 ml·min -1·1.73㎡ |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 19 years of age or older
- Patient undergoing percutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents
Key exclusion criteria (4 listed)
- Patient with a life expectancy of less than one year
- Patient who used another drug-eluting stent for percutaneous coronary intervention at study registration time
- Cardiogenic shock
- Pregnancy
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 |
|---|---|---|
| Percutaneous coronary interventionPercutaneous coronary intervention | Procedure or surgery | Moderate renal dysfunction, Normal or mild renal dysfunction, Severe renal dysfunction |
| Orsiro™ or Orsiro_Mission™ stentPercutaneous coronary intervention with Orsiro™ or Orsiro_Mission™ stents | Device | Moderate renal dysfunction, Normal or mild renal dysfunction, Severe renal dysfunction |
Primary outcome
Target-lesion failure (TLF)
Time frame: Within one year after the intervention
Number of participants with Target-lesion failure (TLF), defined as composite of cardiac death, target vessel-related myocardial infarction (TVMI) and ischemia-driven target-lesion revascularization (TLR) at 1 year
9 secondary outcomes
Number of participants with all cause death
Time frame: Within three years after the intervention
Number of participants with cardiac death
Time frame: Within three years after the intervention
Number of participants with myocardial infarction
Time frame: Within three years after the intervention
Number of participants with composite of death or myocardial infarction
Time frame: Within three years after the intervention
Number of participants with composite of cardiac death or myocardial infarction
Time frame: Within three years after the intervention
Number of participants with target-vessel revascularization
Time frame: Within three years after the intervention
Number of participants with target-lesion revascularization
Time frame: Within three years after the intervention
Number of participants with stent thrombosis
Time frame: Within three years after the intervention
Number of participants with target-vessel failure
Time frame: Within three years after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Mahn-Won Park study chair
Daejeon St. Mary's Hospital , The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous coronary intervention and Orsiro™ or Orsiro_Mission™ stent in people with Chronic Kidney Diseases and Coronary Artery Disease, run by The Catholic University of Korea at 1 site 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
This study is still under way. Results are not available in the source record yet.
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?
Target-lesion failure (TLF) (time frame: Within one year after the intervention). 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 26 Jun 2024.