An interventional study of TRADENT Scoring Balloon and Conventional Non-Scoring Coronary Balloon in Coronary Artery Disease (CAD), sponsored by Ulsan University Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Ulsan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 580 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Ulsan University Hospital is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: TRADENT Scoring Balloon
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.
Device: Conventional Non-Scoring Coronary Balloon
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.
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.
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).
Time frame: Immediately after lesion preparation, before final Drug-Coated Balloon or Drug-Eluting Stent treatment
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days after index percutaneous coronary intervention (PCI)
Target Lesion Thrombosis at 30 Days
Percentage of participants with target lesion thrombosis.
Time frame: 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
Time frame: 30 days after index percutaneous coronary intervention (PCI)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Nov 2027, 13 months later.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 13 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ulsan University Hospital