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The prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting PTCA-balloon catheter (SeQuent® Please) combined with provisional spot stenting of DES versus DES for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-coated balloon group | Experimental |
| |
| second-generation drug-eluting stent group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) | Device | using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss | Late lumen loss (LLL) in the lesion segment within 9 months after surgery | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Interventional therapy success rate | including device success rate, lesion success rate and clinical success rate | 3 years |
| Restenosis rate (RR) in the lesion segment | Restenosis rate (RR) in the lesion segment on 9 months after operation |
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Inclusion Criteria:
Patient-related
Lesion-related
Exclusion Criteria:
Patient-related:
Lesion-related:
Concomitant medication related
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Lei, MD | Contact | 13661022415 | nkgaolei2010@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yundai Chen, MD | Chinese PLA General Hospital | Principal Investigator |
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| drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES) | Device | using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions |
|
| 9 months |
| Clinically-driven target lesion revascularization | Clinically-driven target lesion revascularization (CD-TLR) at 30 days and 3, 6, 9, 12, 24 and 36 months postoperatively | 3 years |
| Device-related cardiovascular clinical composite endpoints | including cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization (CD-TLR), called target lesion failure (TLF) for short | 3 years |
| Patient-related cardiovascular clinical composite endpoints | including all-cause mortality, all myocardial infarctions, and any revascularization | 3 years |