Trial · NCT07899021
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
NCT07899021, Not applicable, Not yet recruiting, Ulsan University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention. Trials, record NCT07899021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899021
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
- NCT number
- NCT07899021
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 580 participants, estimated
- Lead sponsor
- Ulsan University Hospital
- Conditions
- Coronary Artery Disease (CAD)
- Interventions
- TRADENT Scoring Balloon, Conventional Non-Scoring Coronary Balloon
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute Gain | 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). |
| Secondary | Percentage of Participants With Successful Lesion Preparation | Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment | 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. |
| Secondary | Drug-Coated Balloon (DCB)-Alone Treatment Rate | Periprocedural (at completion of index PCI) | 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. |
| Secondary | Bailout Stenting Rate | Periprocedural (during index percutaneous coronary intervention [PCI]) | 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. |
| Secondary | Severe Dissection After Lesion Preparation | Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment | Percentage of participants with National Heart, Lung, and Blood Institute (NHLBI) type C, D, E or F dissection on the angiogram after lesion preparation. |
| Secondary | Residual Diameter Stenosis After Lesion Preparation | Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment | Residual diameter stenosis (%) measured by quantitative coronary angiography (QCA). |
| Secondary | Residual Diameter Stenosis at Final Angiography | Periprocedural (at completion of index percutaneous coronary intervention [PCI]) | Residual diameter stenosis (%) measured by quantitative coronary angiography (QCA). |
| Secondary | Minimum Lumen Diameter After Lesion Preparation | Immediately after lesion preparation, before definitive drug-coated balloon (DCB) or drug-eluting stent (DES) treatment | Minimum lumen diameter (MLD) in millimeters (mm) measured by quantitative coronary angiography (QCA). |
| Secondary | Minimum Lumen Diameter at Final Angiography | Periprocedural (at completion of index percutaneous coronary intervention [PCI]) | Minimum lumen diameter (MLD) in millimeters (mm) measured by quantitative coronary angiography (QCA). A larger value indicates a wider lumen. |
| Secondary | Initial Crossing Success | Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI]) | Percentage of participants in whom the assigned balloon reached the intended position at the first attempt without prior facilitation balloon. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07899021
GET https://conductscience.org/api/trials/v1/NCT07899021/registered