Coronary Artery DiseasePhase 4SMART-CHOICE4NCT05066789
CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 4
A Phase 4 study testing Type of stent and Duration of DAPT in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is multi-center, open label, two-by-two factorial, randomized, noninferiority trial to compare the efficacy and safety of polymer-free cobalt-chromium thin drug-coated stents (BioFreedom Ultra) with biodegradable polymer ultrathin sirolimus-eluting stents (Orsiro Mission) and prasugrel monotherapy after… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Type of stent and Duration of DAPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2022to 22 Mar 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients presenting with ACS (ST-elevation myocardial infarction [STEMI], non-ST-elevation myocardial infarction [NSTEMI], or unstable angina)
- Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents (DES) in native coronary artery or graft
Who cannot join
- Patients unable to provide consent
- Patients with known intolerance to aspirin, clopidogrel, prasugrel, or major components of drug-eluting stents
- Patients who have non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Patients who need chronic anti-coagulation therapy
- Patients with active pathological bleeding
- Pregnant or lactating women
Show all 10Show fewer
- Additional Exclusion Criteria for Antiplatelet Comparison Study:
- Patients with history of stroke or transient ischemic attack
- Patients 75 years of age or older
- Patients weighing less than 60 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Polymer-Free Cobalt-Chromium Thin Drug-Coated Stents With Biodegradable Polymer Ultrathin Sirolimus-Eluting Stents and Prasugrel Monotherapy With Conventional 12-Month Dual Antiplatelet Therapy
This study is multi-center, open label, two-by-two factorial, randomized, noninferiority trial to compare the efficacy and safety of polymer-free cobalt-chromium thin drug-coated stents (BioFreedom Ultra) with biodegradable polymer ultrathin sirolimus-eluting stents (Orsiro Mission) and prasugrel monotherapy after 1-month dual antiplatelet therapy (DAPT) of aspirin plus prasugrel with 12-month DAPT of aspirin plus prasugrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Read the detailed description
Polymer is the key component of drug-eluting stents (DES) for facilitation of drug loading and control of drug release. However, durable polymer of the 1st generation DES has been considered to induce inflammation and to be associated with fatal complications such as very late stent thrombosis. To overcome this shortcoming, biodegradable polymer has been applied to the DES system. In several head-to-head comparison, ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent demonstrated comparable or superior outcomes compared with durable polymer everolimus-eluting stents. As a result, Orsiro stent is considered one of the standard contemporary DESs.
On the other hand, polymer-free drug-coated stents (DCS) have been developed as an alternative to durable and biodegradable polymer DES. The biolimus A9-coated BioFreedom stent is the representative polymer-free drug-coated stent and was superior to a bare-metal stent in patients treated with 1-month dual antiplatelet therapy (DAPT). However, it failed to show noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population, mainly due to increased target lesion revascularization (TLR). On top of possible insufficient or uncontrolled drug delivery at stented site due to absence of a drug carrier, thick strut (112 µm) and stainless steel alloy may explain a higher rate of TLR in the BioFreedom stent group compared with the Orsiro stent group. The BioFreedom Ultra stent is a novel cobalt-chromium thin stent (84 µm) with biolimus A9-coating. With advancement in stent alloy and strut thickness, treatment efficacy and safety of the BioFreedom Ultra stent would be comparable to the new version of Orsiro stent (Orsiro Mission) among patients with acute coronary syndrome (ACS).
Patients with ACS undergoing percutaneous coronary intervention (PCI) with DES are currently recommended to use 12 months of DAPT, consisting of aspirin and P2Y12 inhibitor. Although use of DAPT reduces ischemic events, including stent thrombosis, bleeding events increase in return. Hence, considering the aforementioned advancement of stent devices, shorter duration of DAPT and switching to a potent P2Y12 inhibitor monotherapy would be possible. This has been demonstrated in several recent studies. However, although prasugrel was superior to ticagrelor in lowering ischemic events, these studies mainly used ticagrelor as a solely used antiplatelet agent, and studies verifying the effect of prasugrel monotherapy after short duration of DAPT are limited to date. In addition, in these studies, DAPT was maintained for mostly at least 3 months in the ACS situation. With advancement of devices, duration of DAPT may be further reduced. In other words, prasugrel monotherapy after 1 month of DAPT of aspirin plus prasugrel would be comparable to 12-month DAPT of aspirin plus prasugrel.
- Conditions
- Coronary Artery Disease
- Being tested
- Type of stent, Duration of DAPT
- Keywords
- Percutaneous Coronary Intervention, Acute coronary syndrome, Antiplatelet Therapy, Drug eluting stent
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of stentDevice
1:1 randomization to biodegradable polymer DES (Orsiro Mission) and polymer-free DCS (Biofreedom)
Duration of DAPTDrug
1:1 randomization to 1-month DAPT thereafter prasugrel monotherapy and 12-month DAPT (aspirin + prasugrel)
| Study group | Role | What they receive |
|---|---|---|
| Biodegradable Polymer DES | Active comparator | Patients will be randomized to either the polymer-free drug-coated stent (DCS) group or the biodegradable polymer drug-eluting (DES) group with 1:1 ratio.
This group will use Orsiro Mission stent during the index procedure. Receives: Device: Type of stent |
| 12-month DAPT | Active comparator | Patients will be randomized to either the prasugrel monotherapy group or the 12-month dual antiplatelet therapy (DAPT) group with 1:1 ratio unless patients have additional exclusion criteria for antiplatelet study.
This group will receive 12-month DAPT of aspirin (100mg once daily) plus prasugrel (10mg once daily). Receives: Drug: Duration of DAPT |
| Polymer-free DCS | Experimental | Patients will be randomized to either the polymer-free drug-coated stent (DCS) group or the biodegradable polymer drug-eluting (DES) group with 1:1 ratio.
This group will use BioFreedom Ultra stent during the index procedure. Receives: Device: Type of stent |
| Prasugrel monotherapy | Experimental | Patients will be randomized to either the prasugrel monotherapy group or the 12-month dual antiplatelet therapy (DAPT) group with 1:1 ratio unless patients have additional exclusion criteria for antiplatelet study.
This group will receive aspirin (100mg once daily) plus prasugrel (10mg once daily) for 1 month and thereafter prasugrel (10mg once daily) alone. Receives: Drug: Duration of DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Comparison Study: target-lesion failure (TLF)
a composite of cardiac death, target vessel-myocardial infarction, or clinically indicated target-lesion revascularization by percutaneous or surgical methods
Measured: 1 year
Antiplatelet Comparison Study: net adverse clinical events (NACE)
a composite of major adverse cardiac and cerebrovascular events (MACCE) and clinically relevant bleeding
Measured: 1 year
Secondary outcomes (26)
Stent Comparison Study: TLF
a composite of cardiac death, target vessel-myocardial infarction, or clinically indicated target-lesion revascularization by percutaneous or surgical methods
Measured: 3 years
Stent Comparison Study: target-vessel failure
a composite of cardiac death, target vessel-MI, or clinically indicated target-vessel revascularization by percutaneous or surgical methods
Measured: 1 and 3 years
Stent Comparison Study: cardiac death
cardiac death
Measured: 1 and 3 years
Stent Comparison Study: target-vessel myocardial infarction (MI)
target-vessel MI
Measured: 1 and 3 years
Stent Comparison Study: clinically indicated TLR
clinically indicated TLR
Measured: 1 and 3 years
Stent Comparison Study: stent thrombosis
definite or probable by Academic Research Consortium [ARC] definition
Measured: 1 and 3 years
Stent Comparison Study: clinically indicated target-vessel revascularization (TVR)
clinically indicated target-vessel revascularization (TVR)
Measured: 1 and 3 years
Stent Comparison Study: cardiac death or MI
cardiac death or MI
Measured: 1 and 3 years
Stent Comparison Study: cardiac death, MI, or stent thrombosis
cardiac death, MI, or stent thrombosis
Measured: 1 and 3 years
Stent Comparison Study: all-cause death
all-cause death
Measured: 1 and 3 years
Stent Comparison Study: MI
MI
Measured: 1 and 3 years
Stent Comparison Study: all-cause death or MI
all-cause death or MI
Measured: 1 and 3 years
Stent Comparison Study: any revascularization
any revascularization
Measured: 1 and 3 years
Stent Comparison Study: restricted mean survival time for the TLF
restricted mean survival time for the TLF
Measured: 1 and 3 years
Antiplatelet Comparison Study: MACCE
a composite of all-cause death, MI, and stroke
Measured: 1 year
Antiplatelet Comparison Study: clinically relevant bleeding
bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding
Measured: 1 year
Antiplatelet Comparison Study: all-cause death
all-cause death
Measured: 1 year
Antiplatelet Comparison Study: MI
MI
Measured: 1 year
Antiplatelet Comparison Study: stroke
stroke
Measured: 1 year
Antiplatelet Comparison Study: cardiac death
cardiac death
Measured: 1 year
Antiplatelet Comparison Study: stent thrombosis
definite or probable by ARC definition
Measured: 1 year
Antiplatelet Comparison Study: all-cause death or MI
all-cause death or MI
Measured: 1 year
Antiplatelet Comparison Study: cardiac death or MI
cardiac death or MI
Measured: 1 year
Antiplatelet Comparison Study: cardiac death, MI, or stent thrombosis
cardiac death, MI, or stent thrombosis
Measured: 1 year
Antiplatelet Comparison Study: BARC type 3 or 5 bleeding
BARC type 3 or 5 bleeding
Measured: 1 year
Antiplatelet Comparison Study: restricted mean survival time for the NACE
restricted mean survival time for the NACE
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start17 Jan 2022
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Why it stopped: Ending early registration due to low registration status and lack of research
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.
- More trials run by Samsung Medical CenterThe 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
- Factorial
- Model description
- multi-center, open label, two-by-two factorial, randomized, noninferiority trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066789
- Sponsor's protocol ID
- CHOICE-4
- Acronym
- SMART-CHOICE4
- Status last verified
- May 2025
- First submitted
- 15 Sep 2021
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Polymer-Free Cobalt-Chromium Thin Drug-Coated Stents With Biodegradable Polymer Ultrathin Sirolimus-Eluting Stents and Prasugrel Monotherapy With Conventional 12-Month Dual Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT05066789
- Acronym / sponsor ID
- SMART-CHOICE4 / CHOICE-4
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Acute coronary syndrome, Antiplatelet Therapy, Drug eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ending early registration due to low registration status and lack of research
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 4 Oct 2021 (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.
This study is multi-center, open label, two-by-two factorial, randomized, noninferiority trial to compare the efficacy and safety of polymer-free cobalt-chromium thin drug-coated stents (BioFreedom Ultra) with biodegradable polymer ultrathin sirolimus-eluting stents (Orsiro Mission) and prasugrel monotherapy after 1-month dual antiplatelet therapy (DAPT) of aspirin plus prasugrel with 12-month DAPT of aspirin plus prasugrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention.
Detailed description
Polymer is the key component of drug-eluting stents (DES) for facilitation of drug loading and control of drug release. However, durable polymer of the 1st generation DES has been considered to induce inflammation and to be associated with fatal complications such as very late stent thrombosis. To overcome this shortcoming, biodegradable polymer has been applied to the DES system. In several head-to-head comparison, ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent demonstrated comparable or superior outcomes compared with durable polymer everolimus-eluting stents. As a result, Orsiro stent is considered one of the standard contemporary DESs.
On the other hand, polymer-free drug-coated stents (DCS) have been developed as an alternative to durable and biodegradable polymer DES. The biolimus A9-coated BioFreedom stent is the representative polymer-free drug-coated stent and was superior to a bare-metal stent in patients treated with 1-month dual antiplatelet therapy (DAPT). However, it failed to show noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population, mainly due to increased target lesion revascularization (TLR). On top of possible insufficient or uncontrolled drug delivery at stented site due to absence of a drug carrier, thick strut (112 µm) and stainless steel alloy may explain a higher rate of TLR in the BioFreedom stent group compared with the Orsiro stent group. The BioFreedom Ultra stent is a novel cobalt-chromium thin stent (84 µm) with biolimus A9-coating. With advancement in stent alloy and strut thickness, treatment efficacy and safety of the BioFreedom Ultra stent would be comparable to the new version of Orsiro stent (Orsiro Mission) among patients with acute coronary syndrome (ACS).
Patients with ACS undergoing percutaneous coronary intervention (PCI) with DES are currently recommended to use 12 months of DAPT, consisting of aspirin and P2Y12 inhibitor. Although use of DAPT reduces ischemic events, including stent thrombosis, bleeding events increase in return. Hence, considering the aforementioned advancement of stent devices, shorter duration of DAPT and switching to a potent P2Y12 inhibitor monotherapy would be possible. This has been demonstrated in several recent studies. However, although prasugrel was superior to ticagrelor in lowering ischemic events, these studies mainly used ticagrelor as a solely used antiplatelet agent, and studies verifying the effect of prasugrel monotherapy after short duration of DAPT are limited to date. In addition, in these studies, DAPT was maintained for mostly at least 3 months in the ACS situation. With advancement of devices, duration of DAPT may be further reduced. In other words, prasugrel monotherapy after 1 month of DAPT of aspirin plus prasugrel would be comparable to 12-month DAPT of aspirin plus prasugrel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- multi-center, open label, two-by-two factorial, randomized, noninferiority trial
| Arm | Type | Receives |
|---|---|---|
| Biodegradable Polymer DES | Active comparator | Device: Type of stentPatients will be randomized to either the polymer-free drug-coated stent (DCS) group or the biodegradable polymer drug-eluting (DES) group with 1:1 ratio. This group will use Orsiro Mission stent during the index procedure. |
| 12-month DAPT | Active comparator | Drug: Duration of DAPTPatients will be randomized to either the prasugrel monotherapy group or the 12-month dual antiplatelet therapy (DAPT) group with 1:1 ratio unless patients have additional exclusion criteria for antiplatelet study. This group will receive 12-month DAPT of aspirin (100mg once daily) plus prasugrel (10mg once daily). |
| Polymer-free DCS | Experimental | Device: Type of stentPatients will be randomized to either the polymer-free drug-coated stent (DCS) group or the biodegradable polymer drug-eluting (DES) group with 1:1 ratio. This group will use BioFreedom Ultra stent during the index procedure. |
| Prasugrel monotherapy | Experimental | Drug: Duration of DAPTPatients will be randomized to either the prasugrel monotherapy group or the 12-month dual antiplatelet therapy (DAPT) group with 1:1 ratio unless patients have additional exclusion criteria for antiplatelet study. This group will receive aspirin (100mg once daily) plus prasugrel (10mg once daily) for 1 month and thereafter prasugrel (10mg once daily) alone. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients presenting with ACS (ST-elevation myocardial infarction [STEMI], non-ST-elevation myocardial infarction [NSTEMI], or unstable angina)
- Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents (DES) in native coronary artery or graft
Key exclusion criteria (10 listed)
- Patients unable to provide consent
- Patients with known intolerance to aspirin, clopidogrel, prasugrel, or major components of drug-eluting stents
- Patients who have non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Patients who need chronic anti-coagulation therapy
- Patients with active pathological bleeding
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 |
|---|---|---|
| Type of stent1:1 randomization to biodegradable polymer DES (Orsiro Mission) and polymer-free DCS (Biofreedom) | Device | Biodegradable Polymer DES, Polymer-free DCS |
| Duration of DAPT1:1 randomization to 1-month DAPT thereafter prasugrel monotherapy and 12-month DAPT (aspirin + prasugrel) | Drug | 12-month DAPT, Prasugrel monotherapy |
Primary outcome
Stent Comparison Study: target-lesion failure (TLF)
Time frame: 1 year
a composite of cardiac death, target vessel-myocardial infarction, or clinically indicated target-lesion revascularization by percutaneous or surgical methods
Antiplatelet Comparison Study: net adverse clinical events (NACE)
Time frame: 1 year
a composite of major adverse cardiac and cerebrovascular events (MACCE) and clinically relevant bleeding
26 secondary outcomes
Stent Comparison Study: TLF
Time frame: 3 years
Stent Comparison Study: target-vessel failure
Time frame: 1 and 3 years
Stent Comparison Study: cardiac death
Time frame: 1 and 3 years
Stent Comparison Study: target-vessel myocardial infarction (MI)
Time frame: 1 and 3 years
Stent Comparison Study: clinically indicated TLR
Time frame: 1 and 3 years
Stent Comparison Study: stent thrombosis
Time frame: 1 and 3 years
Stent Comparison Study: clinically indicated target-vessel revascularization (TVR)
Time frame: 1 and 3 years
Stent Comparison Study: cardiac death or MI
Time frame: 1 and 3 years
Stent Comparison Study: cardiac death, MI, or stent thrombosis
Time frame: 1 and 3 years
Stent Comparison Study: all-cause death
Time frame: 1 and 3 years
Stent Comparison Study: MI
Time frame: 1 and 3 years
Stent Comparison Study: all-cause death or MI
Time frame: 1 and 3 years
Stent Comparison Study: any revascularization
Time frame: 1 and 3 years
Stent Comparison Study: restricted mean survival time for the TLF
Time frame: 1 and 3 years
Antiplatelet Comparison Study: MACCE
Time frame: 1 year
Antiplatelet Comparison Study: clinically relevant bleeding
Time frame: 1 year
Antiplatelet Comparison Study: all-cause death
Time frame: 1 year
Antiplatelet Comparison Study: MI
Time frame: 1 year
Antiplatelet Comparison Study: stroke
Time frame: 1 year
Antiplatelet Comparison Study: cardiac death
Time frame: 1 year
Antiplatelet Comparison Study: stent thrombosis
Time frame: 1 year
Antiplatelet Comparison Study: all-cause death or MI
Time frame: 1 year
Antiplatelet Comparison Study: cardiac death or MI
Time frame: 1 year
Antiplatelet Comparison Study: cardiac death, MI, or stent thrombosis
Time frame: 1 year
Antiplatelet Comparison Study: BARC type 3 or 5 bleeding
Time frame: 1 year
Antiplatelet Comparison Study: restricted mean survival time for the NACE
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Ending early registration due to low registration status and lack of research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- 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.
Joo-Yong Hahn, MD, PhD study chair
Samsung Medical Center
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 Type of stent and Duration of DAPT in people with Coronary Artery Disease, run by Samsung Medical Center 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 May 2025. 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?
The study was stopped early (reason given: Ending early registration due to low registration status and lack of research). Results are not available in the source record.
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 Comparison Study: target-lesion failure (TLF) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 18 May 2025.