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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
Drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are eligible for percutaneous coronary intervention (PCI).1 During long-term follow-up, remained metallic stent strut continuously related with stent-related cardiovascular events.2 As an alternative option to DES, drug-coated balloon (DCB) which has benefit of having shorter DAPT maintenance duration due to the absence of metallic scaffolds and polymers, has been introduced. Based on meta-analysis based on many randomized clinical trials (RCT),3,4 its use has been established in in-stent restenosis of bare-metal stents and DES.5 Furthermore, recent RCTs demonstrated efficacy and safety of DCB in de novo coronary lesions in small vessels with reference vessel size <3.0mm.6,7 For the patients with de novo, non-complex coronary artery lesions, REC-CAGEFREE I tested the non-inferiority of DCB angioplasty with DES implantation, irrespective of vessel diameter.8 Overall, 2272 patients were randomly assigned to the DCB or the DES group. At 2 years, adverse events occurred in 6.4% of DCB group and 3.4% of DES group and failed to prove the non-inferiority of DCB angioplasty (P for non-inferiority=0.65). Regarding the heterogenous results, it is questionable that DCB angioplasty for large de novo lesions is safe and effective compared with DES implantation.
On this background, the current study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting stent | Active Comparator | In DES group, latest second-generation DES will be used in accordance with standard practice guideline. |
|
| Drug-coated balloon | Experimental | In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-eluting stent implantation | Procedure | IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio >0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups. In DES group, latest second-generation DES will be used in accordance with standard practice guideline. |
| Measure | Description | Time Frame |
|---|---|---|
| Late-lumen loss | Mean difference of late-lumen loss between DCB and DES in IVUS | 9 months after last patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal lumen diameter in QCA | Mean difference of minimal lumen diameter in QCA | 9 months after last patient enrollment |
| % diameter stenosis in QCA | Mean difference of % diameter stenosis in QCA |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung Hun Lee, MD, PhD | Contact | +82-62-220-6246 | lsh8602@naver.com | |
| Joon Ho Ahn, MD, PhD | Contact | +82-62-220-5778 | yhbky@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Joon Hong, MD, PhD | Chonnam National University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Not yet recruiting | Busan | Busan | 49269 | South Korea |
Yes After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
After publication of main paper.
Executive Committee will discuss to share the de-identified data upon reasonable requests.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: V1.0 | Apr 24, 2025 |
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prospective, multi-center, off-label, randomized controlled, non-inferiority trial.
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|
| Drug-coated balloon angioplasty | Procedure | IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio >0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups. In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds. |
|
| 9 months after last patient enrollment |
| Minimal lumen diameter in IVUS | Mean difference of minimal lumen diameter in IVUS | 9 months after last patient enrollment |
| Cardiovascular death | Cardiovascular death | 1 year after last patient enrollment |
| All-cause death | All-cause death | 1 year after last patient enrollment |
| Rate of target vessel-MI | Target vessel-MI | 1 year after last patient enrollment |
| Rate of non-fatal MI | Non-fatal MI | 1 year after last patient enrollment |
| Rate of target lesion revascularization | Clinically indicated target lesion revascularization | 1 year after last patient enrollment |
| Rate of target vessel revascularization | Clinically indicated target vessel revascularization | 1 year after last patient enrollment |
| Rate of any revascularization | Any revascularization | 1 year after last patient enrollment |
| Rate of vessel or stent thrombosis | Definite or probable thrombosis | 1 year after last patient enrollment |
| Cardiovascular death or target vessel-related myocardial infarction | A composite of cardiovascular death or target vessel-related myocardial infarction | 1 year after last patient enrollment |
| All-cause death or non-fatal MI | A composite of all-cause death or non-fatal myocardial infarction | 1 year after last patient enrollment |
| Target vessel failure | A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target vessel revascularization | 1 year after last patient enrollment |
| Target lesion failure | A composite of cardiovascular death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization | 1 year after last patient enrollment |
| Cardiovascular death, target-vessel MI, or vessel or stent thrombosis | A composite of cardiovascular death, target-vessel MI, or vessel or stent thrombosis | 1 year after last patient enrollment |
| All-cause death, non-fatal myocardial infarction, or target vessel revascularization | A composite of all-cause death, non-fatal myocardial infarction, or target vessel revascularization | 1 year after last patient enrollment |
| BARC type 2, 3, or 5 bleeding | BARC type 2, 3, or 5 bleeding | 1 year after last patient enrollment |
| Cerebrovascular accident | Ischemic stroke, hemorrhagic stroke, or transient ischemic attack | 1 year after last patient enrollment |
| Keimyung University Dongsan Hospital | Not yet recruiting | Daegu | Daegu | 42601 | South Korea |
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| Chonnam National University | Recruiting | Gwangju | Gwangju | 61469 | South Korea |
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| Jeonbuk National University Hospital | Not yet recruiting | Jeonju | Jeonju | 54907 | South Korea |
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| Samsung Medical Center | Not yet recruiting | Seoul | Seoul | 06351 | South Korea |
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| Ewha Womans University Mokdong Hospital | Not yet recruiting | Seoul | Seoul | 07985 | South Korea |
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| Korea University Guro Hospital | Not yet recruiting | Seoul | Seoul | 08308 | South Korea |
|
| Ulsan University Hospital | Not yet recruiting | Ulsan | Ulsan | 44033 | South Korea |
|
| Apr 24, 2025 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: V2.0 | May 6, 2026 | May 8, 2026 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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