Impact of Procedural Factors on Drug-Coated Balloon Outcomes in Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanjing First Hospital, Nanjing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with de novo coronary lesions who are scheduled for planned drug-coated balloon PCI
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: DCB-Treated De Novo Lesion
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 monthsSponsors and contacts
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Source ClinicalTrials.gov