Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease

Nanjing First Hospital, Nanjing Medical University500 enrolled

Overview

This registry aimed to investigate drug-coated balloon procedural factors (particularly delivery time and inflation duration) to evaluate the impact on angiographic and clinical outcomes in patients undergoing percutaneous coronary intervention for de novo coronary lesions.

This study aimed to systematically investigate drug-coated balloon procedural factors including Y-to-B delivery time, inflation duration among patients with de novo coronary lesions undergoing PCI.The impact of these procedural factors on angiographic and clinical outcomes will be analyzed.Based on these findings, novel techniques and pretreatment strategies may be proposed to optimize the DCB treatment process

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

PCI Drug-coated Balloon Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years 2. Stable coronary artery disease or unstable angina 3. De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm) 4. Planned DCB strategy for PCI 5. Written informed consent Exclusion Criteria: 1. Acute myocardial infarction within 72 hours 2. Severe heart failure (NYHA class IV) 3. Severe hepatic or renal insufficiency 4. Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy 5. Life expectancy \<12 months 6. Pregnancy or breastfeeding 7. Concurrent participation in another clinical trial 8. In-stent restenosis 9. Unsuccessful recanalization of main vessel or side branch chronic total occlusion 10. Hemodynamic instability

Locations (7)

Chuzhou First People's Hospital

Chuzhou, Anhui, China

RECRUITING

Tongling People's Hospital

Tongling, Anhui, China

RECRUITING

Huai'an Second People's Hospital

Huai'an, Jiangsu, China

Outcomes

Primary Outcomes

Number of Participants with Target Lesion Restenosis

Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up

Time frame: 6-12 months

Secondary Outcomes

Number of Participants with Target Vessel Failure

Composite of cardiac death, target-vessel myocardial infarction (TVMI), and clinically driven target-vessel revascularization(TVR)

Time frame: 6-12 months

Central Contacts

Fei Ye, MD

CONTACT

18951670287 doctor_ye@126.com

Tian-lei Zhang, MD

CONTACT

Data from ClinicalTrials.gov

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