Trial · NCT07899021
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Facilitation Balloon Use | Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI]) | Percentage of participants in whom a protocol-defined facilitation balloon was used. |
| Secondary | Assigned-Balloon Strategy Success | Periprocedural (during lesion preparation at index percutaneous coronary intervention [PCI]) | Percentage of participants in whom the assigned balloon was inflated at the intended position and withdrawn without problems, regardless of permitted facilitation balloon use. |
| Secondary | Additional Lesion Modification | Periprocedural (during index percutaneous coronary intervention [PCI]) | Percentage of participants requiring non-assigned plain, scoring or cutting balloon, intravascular lithotripsy (IVL) or atherectomy. Protocol-defined facilitation balloon is not counted. |
| Secondary | Final Treatment Device | Periprocedural (at completion of index percutaneous coronary intervention [PCI]) | 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. |
| Secondary | Target Lesion Failure at 30 Days | 30 days after index percutaneous coronary intervention (PCI) | 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. |
| Secondary | Target Lesion Thrombosis at 30 Days | 30 days after index percutaneous coronary intervention (PCI) | Percentage of participants with target lesion thrombosis. |
| Secondary | Bleeding Academic Research Consortium (BARC) Type 3 or 5 Bleeding at 30 Days | 30 days after index percutaneous coronary intervention (PCI) | Percentage of participants with Bleeding Academic Research Consortium Type 3 or 5 Bleeding |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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