Impact of Drug-Coated Balloon Procedural Factors on Angiographic and Clinical Outcomes of Percutaneous Coronary Intervention for De Novo Lesions: A Multicenter, Prospective, Observational Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 500
- Locations
- 7
- Primary Endpoint
- Number of Participants with Target Lesion Restenosis
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Stable coronary artery disease or unstable angina
- •De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm)
- •Planned DCB strategy for PCI
- •Written informed consent
Exclusion Criteria
- •Acute myocardial infarction within 72 hours
- •Severe heart failure (NYHA class IV)
- •Severe hepatic or renal insufficiency
- •Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy
- •Life expectancy <12 months
- •Pregnancy or breastfeeding
- •Concurrent participation in another clinical trial
- •In-stent restenosis
- •Unsuccessful recanalization of main vessel or side branch chronic total occlusion
- •Hemodynamic instability
Arms & Interventions
DCB-Treated De Novo Lesion
Patients undergoing drug-coated balloon treatment for de novo coronary lesions
Outcomes
Primary Outcomes
Number of Participants with Target Lesion Restenosis
Time Frame: 6-12 months
Percentage diameter stenosis at the target lesion as assessed by angiography at follow-up
Secondary Outcomes
- Number of Participants with Target Vessel Failure(6-12 months)
Investigators
Ye-fei
chief physician
Nanjing First Hospital, Nanjing Medical University