Coronary Artery Disease (CAD)TRAD-PREPNCT07899021
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
A study testing TRADENT Scoring Balloon and Conventional Non-Scoring Coronary Balloon in people with Coronary Artery Disease (CAD), run by Ulsan University Hospital.
Trial summary
This study will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- TRADENT Scoring Balloon and Conventional Non-Scoring Coronary Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- 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
- Age ≥19 years and able to provide written informed consent.
- Patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) requiring percutaneous coronary intervention (PCI).
- Patients for whom the operator has planned and documented a drug-coated balloon (DCB)-first strategy with the intention of achieving drug-coated balloon (DCB)-alone treatment of the index lesion before randomization. Drug-eluting stent (DES) may be used if lesion preparation is inadequate or required for patient safety.
- Native coronary de novo lesion with visually estimated diameter stenosis (DS) ≥50% and ≤100%.
- A target lesion for which a study balloon suitable for a balloon-to-artery ratio of 1.0 (1:1) based on the visually estimated reference vessel diameter (RVD) can be selected in either treatment group.
- Successful guidewire crossing of the target lesion, with no predilatation of the target lesion before randomization.
- Ability to designate one target lesion per participant.
Who cannot join
- ST-segment elevation myocardial infarction (STEMI), cardiogenic shock, or ongoing hemodynamic instability within 72 hours before index percutaneous coronary intervention (PCI).
- Unprotected left main coronary artery disease or saphenous vein graft lesion.
- Substantial thrombus burden in the target lesion.
- Balloon dilatation or other plaque-modification treatment of the target lesion before randomization.
- Uncontrolled contraindication to the study drug, contrast media, or any component of the study device.
- Pregnancy or breastfeeding.
Show all 9Show fewer
- Life expectancy <1 year.
- Inability to complete the 30-day follow-up.
- Participation in another competing interventional clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Trial of TRADENT™ Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
This study will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions. The study will evaluate angiographic acute gain after lesion preparation and assess whether improved lesion preparation leads to a higher rate of successful drug-coated balloon (DCB)-alone treatment. The study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial.
Read the detailed description
This study will evaluate whether the TRADENT™ coronary scoring balloon provides better lesion preparation than a conventional non-scoring balloon in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions.
Participants will be randomly assigned in a 1:1 ratio to lesion preparation with either the TRADENT™ scoring balloon or a conventional non-scoring balloon. The primary assessment will focus on angiographic acute gain measured by quantitative coronary angiography (QCA) immediately after lesion preparation and before definitive treatment.
The study will also assess the quality of lesion preparation and whether improved lesion preparation facilitates drug-coated balloon (DCB)-alone treatment and reduces the need for bailout stenting. Angiographic outcomes will be evaluated by an independent QCA core laboratory blinded to treatment assignment, and clinical events will be adjudicated by an independent Clinical Events Committee.
This is a prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE) study. If lesion preparation is inadequate or additional treatment is required for patient safety, further treatment including drug-eluting stent (DES) implantation may be performed according to the investigator's clinical judgment.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- TRADENT Scoring Balloon, Conventional Non-Scoring Coronary Balloon
- Keywords
- Coronary Artery Disease, De Novo Coronary Lesion, Drug-Coated Balloon, Scoring Balloon, Lesion Preparation, Acute Gain, TRADENT, Drug-Coated Balloon-First Strategy
- 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.
TRADENT Scoring BalloonDevice
TRADENT™ coronary scoring balloon will be used for lesion preparation in de novo coronary lesions planned for a drug-coated balloon (DCB)-first strategy. The balloon will be selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter and used for lesion preparation before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment. If the assigned balloon fails to cross the lesion, a smaller plain balloon may be used solely for crossing facilitation. The assigned TRADENT™ scoring balloon remains the designated lesion-preparation intervention.
Conventional Non-Scoring Coronary BalloonDevice
A conventional non-scoring coronary balloon (compliant, semi-compliant, or non-compliant) will be used for lesion preparation in de novo coronary lesions planned for a Drug-Coated Balloon(DCB)-First Strategy. The balloon will be selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter and used for lesion preparation before definitive Drug-Coated Balloon(DCB) or Drug-eluting stent (DES) treatment . If the assigned balloon fails to cross the lesion, a smaller plain balloon may be used solely for crossing facilitation.
| Study group | Role | What they receive |
|---|---|---|
| TRADENT Scoring Balloon | Experimental | Participants will undergo lesion preparation using the TRADENT™ coronary scoring balloon selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter. If the assigned balloon cannot cross the lesion, a smaller plain balloon may be used for crossing facilitation. Receives: Device: TRADENT Scoring Balloon |
| Conventional Non-Scoring Balloon | Active comparator | Participants will undergo lesion preparation using a conventional non-scoring coronary balloon selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter. If the assigned balloon cannot cross the lesion, a smaller plain balloon may be used for crossing facilitation. Receives: Device: Conventional Non-Scoring Coronary Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Gain
Acute gain, defined as post-preparation Minimum Lumen Diameter minus baseline Minimum Lumen Diameter, measured by blinded Quantitative Coronary Angiography (QCA) core laboratory immediately after completion of lesion preparation with the assigned balloon (regardless of protocol-defined facilitation balloon use) and before final Drug-Coated Balloon/Drug-Eluting Stent treatment or rescue therapy. Unit: millimeters (mm).
Measured: Immediately after lesion preparation, before final Drug-Coated Balloon or Drug-Eluting Stent treatment
Secondary outcomes (16)
Percentage of Participants With Successful Lesion Preparation
Successful lesion preparation is a composite binary outcome assessed once per participant on the angiogram obtained immediately after lesion preparation with the assigned balloon. A participant is classified as successful if both of the following are met: (a) residual diameter stenosis is 30% or less and (b) Thrombolysis in Myocardial Infarction (TIMI) flow grade is 3. A participant who does not meet both is classified as not successful. The two assessments are not reported separately. The single reported value is the percentage of participants classified as successful.
Measured: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Drug-Coated Balloon (DCB)-Alone Treatment Rate
Percentage of randomized participants achieving DCB-alone treatment of the target lesion. For each participant, two assessments at index percutaneous coronary intervention (PCI) are combined into one binary classification: (a) DCB treatment of the target lesion was completed and (b) no stent/scaffold was implanted in the target lesion. A participant is classified as DCB-alone only if both (a) and (b) are met. The two assessments are not reported separately. The single reported value is the percentage of participants classified as DCB-alone.
Measured: Periprocedural (at completion of index PCI)
Bailout Stenting Rate
Percentage of participants with stent implantation for Thrombolysis in Myocardial Infarction (TIMI) flow ≤2, flow-limiting dissection, abrupt closure, excessive recoil, or other immediate safety need, before or after drug-coated balloon (DCB) treatment.
Measured: Periprocedural (during index percutaneous coronary intervention [PCI])
Severe Dissection After Lesion Preparation
Percentage of participants with National Heart, Lung, and Blood Institute (NHLBI) type C, D, E or F dissection on the angiogram after lesion preparation.
Measured: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Residual Diameter Stenosis After Lesion Preparation
Residual diameter stenosis (%) measured by quantitative coronary angiography (QCA).
Measured: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Residual Diameter Stenosis at Final Angiography
Residual diameter stenosis (%) measured by quantitative coronary angiography (QCA).
Measured: Periprocedural (at completion of index percutaneous coronary intervention [PCI])
Minimum Lumen Diameter After Lesion Preparation
Minimum lumen diameter (MLD) in millimeters (mm) measured by quantitative coronary angiography (QCA).
Measured: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Minimum Lumen Diameter at Final Angiography
Minimum lumen diameter (MLD) in millimeters (mm) measured by quantitative coronary angiography (QCA). A larger value indicates a wider lumen.
Measured: Periprocedural (at completion of index percutaneous coronary intervention [PCI])
Initial Crossing Success
Percentage of participants in whom the assigned balloon reached the intended position at the first attempt without prior facilitation balloon.
Measured: Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI])
Facilitation Balloon Use
Percentage of participants in whom a protocol-defined facilitation balloon was used.
Measured: Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI])
Assigned-Balloon Strategy Success
Percentage of participants in whom the assigned balloon was inflated at the intended position and withdrawn without problems, regardless of permitted facilitation balloon use.
Measured: Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI])
Additional Lesion Modification
Percentage of participants requiring non-assigned plain, scoring or cutting balloon, intravascular lithotripsy (IVL) or atherectomy. Protocol-defined facilitation balloon is not counted.
Measured: Periprocedural (during index percutaneous coronary intervention [PCI])
Final Treatment Device
Number of participants by final treatment device of the target lesion: drug-coated balloon (DCB) only, drug-eluting stent (DES) only, DCB+DES, other/incomplete.
Measured: Periprocedural (at completion of index percutaneous coronary intervention [PCI])
Target Lesion Failure at 30 Days
Percentage of participants with at least one of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. Each participant is counted once.
Measured: 30 days after index percutaneous coronary intervention (PCI)
Target Lesion Thrombosis at 30 Days
Percentage of participants with target lesion thrombosis.
Measured: 30 days after index percutaneous coronary intervention (PCI)
Bleeding Academic Research Consortium (BARC) Type 3 or 5 Bleeding at 30 Days
Percentage of participants with Bleeding Academic Research Consortium Type 3 or 5 Bleeding
Measured: 30 days after index percutaneous coronary intervention (PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KangWon National University Hospital, Korea University Guro Hospital, Hanyang University Seoul Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Gyeongsang National University Changwon Hospital
- Responsible party
- Principal investigator, Eun-Seok Shin, Ulsan University Hospital
- Investigators
- Eun-Seok Shin, Professor, Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899021
- Sponsor's protocol ID
- UUH IRB 2026-09-011
- Acronym
- TRAD-PREP
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 27 Oct 2026
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of TRADENT™ Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
- ClinicalTrials.gov ID
- NCT07899021
- Acronym / sponsor ID
- TRAD-PREP / UUH IRB 2026-09-011
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Coronary Artery Disease, De Novo Coronary Lesion, Drug-Coated Balloon, Scoring Balloon, Lesion Preparation, Acute Gain, TRADENT, Drug-Coated Balloon-First Strategy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- KangWon National University Hospital, Korea University Guro Hospital, Hanyang University Seoul Hospital, Kosin University Gospel Hospital, Chonnam National University Hospital, Gyeongsang National University Changwon Hospital
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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 will compare the effectiveness of the TRADENT™ coronary scoring balloon with a conventional non-scoring balloon for lesion preparation in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions. The study will evaluate angiographic acute gain after lesion preparation and assess whether improved lesion preparation leads to a higher rate of successful drug-coated balloon (DCB)-alone treatment. The study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial.
Detailed description
This study will evaluate whether the TRADENT™ coronary scoring balloon provides better lesion preparation than a conventional non-scoring balloon in patients undergoing a drug-coated balloon (DCB)-first percutaneous coronary intervention (PCI) strategy for de novo coronary lesions.
Participants will be randomly assigned in a 1:1 ratio to lesion preparation with either the TRADENT™ scoring balloon or a conventional non-scoring balloon. The primary assessment will focus on angiographic acute gain measured by quantitative coronary angiography (QCA) immediately after lesion preparation and before definitive treatment.
The study will also assess the quality of lesion preparation and whether improved lesion preparation facilitates drug-coated balloon (DCB)-alone treatment and reduces the need for bailout stenting. Angiographic outcomes will be evaluated by an independent QCA core laboratory blinded to treatment assignment, and clinical events will be adjudicated by an independent Clinical Events Committee.
This is a prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE) study. If lesion preparation is inadequate or additional treatment is required for patient safety, further treatment including drug-eluting stent (DES) implantation may be performed according to the investigator's clinical judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRADENT Scoring Balloon | Experimental | Device: TRADENT Scoring BalloonParticipants will undergo lesion preparation using the TRADENT™ coronary scoring balloon selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter. If the assigned balloon cannot cross the lesion, a smaller plain balloon may be used for crossing facilitation. |
| Conventional Non-Scoring Balloon | Active comparator | Device: Conventional Non-Scoring Coronary BalloonParticipants will undergo lesion preparation using a conventional non-scoring coronary balloon selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter. If the assigned balloon cannot cross the lesion, a smaller plain balloon may be used for crossing facilitation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥19 years and able to provide written informed consent.
- Patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome (NSTE-ACS) requiring percutaneous coronary intervention (PCI).
- Patients for whom the operator has planned and documented a drug-coated balloon (DCB)-first strategy with the intention of achieving drug-coated balloon (DCB)-alone treatment of the index lesion before randomization. Drug-eluting stent (DES) may be used if lesion preparation is inadequate or required for patient safety.
- Native coronary de novo lesion with visually estimated diameter stenosis (DS) ≥50% and ≤100%.
- A target lesion for which a study balloon suitable for a balloon-to-artery ratio of 1.0 (1:1) based on the visually estimated reference vessel diameter (RVD) can be selected in either treatment group.
Key exclusion criteria (9 listed)
- ST-segment elevation myocardial infarction (STEMI), cardiogenic shock, or ongoing hemodynamic instability within 72 hours before index percutaneous coronary intervention (PCI).
- Unprotected left main coronary artery disease or saphenous vein graft lesion.
- Substantial thrombus burden in the target lesion.
- Balloon dilatation or other plaque-modification treatment of the target lesion before randomization.
- Uncontrolled contraindication to the study drug, contrast media, or any component of the study device.
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 |
|---|---|---|
| TRADENT Scoring BalloonTRADENT™ coronary scoring balloon will be used for lesion preparation in de novo coronary lesions planned for a drug-coated balloon (DCB)-first strategy. The balloon will be selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter and used for lesion preparation before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment. If the assigned balloon fails to cross the lesion, a smaller plain balloon may be used solely for crossing facilitation. The assigned TRADENT™ scoring balloon remains the designated lesion-preparation intervention. | Device | TRADENT Scoring Balloon |
| Conventional Non-Scoring Coronary BalloonA conventional non-scoring coronary balloon (compliant, semi-compliant, or non-compliant) will be used for lesion preparation in de novo coronary lesions planned for a Drug-Coated Balloon(DCB)-First Strategy. The balloon will be selected at a 1:1 balloon-to-artery ratio based on the visually estimated reference vessel diameter and used for lesion preparation before definitive Drug-Coated Balloon(DCB) or Drug-eluting stent (DES) treatment . If the assigned balloon fails to cross the lesion, a smaller plain balloon may be used solely for crossing facilitation. | Device | Conventional Non-Scoring Balloon |
Primary outcome
Acute Gain
Time frame: Immediately after lesion preparation, before final Drug-Coated Balloon or Drug-Eluting Stent treatment
Acute gain, defined as post-preparation Minimum Lumen Diameter minus baseline Minimum Lumen Diameter, measured by blinded Quantitative Coronary Angiography (QCA) core laboratory immediately after completion of lesion preparation with the assigned balloon (regardless of protocol-defined facilitation balloon use) and before final Drug-Coated Balloon/Drug-Eluting Stent treatment or rescue therapy. Unit: millimeters (mm).
16 secondary outcomes
Percentage of Participants With Successful Lesion Preparation
Time frame: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Drug-Coated Balloon (DCB)-Alone Treatment Rate
Time frame: Periprocedural (at completion of index PCI)
Bailout Stenting Rate
Time frame: Periprocedural (during index percutaneous coronary intervention [PCI])
Severe Dissection After Lesion Preparation
Time frame: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Residual Diameter Stenosis After Lesion Preparation
Time frame: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Residual Diameter Stenosis at Final Angiography
Time frame: Periprocedural (at completion of index percutaneous coronary intervention [PCI])
Minimum Lumen Diameter After Lesion Preparation
Time frame: Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment
Minimum Lumen Diameter at Final Angiography
Time frame: Periprocedural (at completion of index percutaneous coronary intervention [PCI])
Initial Crossing Success
Time frame: Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI])
Facilitation Balloon Use
Time frame: Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI])
Assigned-Balloon Strategy Success
Time frame: Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI])
Additional Lesion Modification
Time frame: Periprocedural (during index percutaneous coronary intervention [PCI])
Final Treatment Device
Time frame: Periprocedural (at completion of index percutaneous coronary intervention [PCI])
Target Lesion Failure at 30 Days
Time frame: 30 days after index percutaneous coronary intervention (PCI)
Target Lesion Thrombosis at 30 Days
Time frame: 30 days after index percutaneous coronary intervention (PCI)
Bleeding Academic Research Consortium (BARC) Type 3 or 5 Bleeding at 30 Days
Time frame: 30 days after index percutaneous coronary intervention (PCI)
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 27 Oct 2026.
- 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.
Eun-Seok Shin, Professor principal investigator
Ulsan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TRADENT Scoring Balloon and Conventional Non-Scoring Coronary Balloon in people with Coronary Artery Disease (CAD), run by Ulsan University Hospital.
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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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.
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?
Contact Eun-Seok Shin, Professor (82-52-250-5020, sesim1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Gain (time frame: Immediately after lesion preparation, before final Drug-Coated Balloon or Drug-Eluting Stent treatment). 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 27 Oct 2026.