NCT05562089

Prevail Drug Balloon Study

Drug-Coated Balloon for the Treatment of De Novo and Restenotic Coronary Artery Lesion: a Prospective Observational Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated, prospective, single-centre, non-randomized, all-comers registry that evaluates the safety and efficacy of any Paclitaxel Drug-Coated Balloon (DCB) for the treatment of coronary de novo lesion, in-stent restenosis, and small vessel disease in patients with coronary artery disease in Hong Kong. The recruitment time frame of this study is 1 year from 1st January 2022 to 30th December 2022.

Detailed description

Procedural strategy, adjuvant medical therapy and antiplatelet regime were left to the discretion of individual operators and their routine clinical practice. In brief, lesion preparation with predilatation using an uncoated balloon with or without the use of adjunctive therapy such as atherectomy or intracoronary lithotripsy to achieve residual diameter stenosis of less than 30% will be required before the usage of the study device. If the lesion meets the inclusion criteria without any of the exclusion criteria, the DCB of appropriate diameter and length can be applied with a minimum inflation time of 30-60 seconds. More than 1 lesion can be treated using the study device in the same vessel. Bail-out stenting is allowed as per operators' discretion. Baseline demographic, clinical and angiographic characteristics of each patient will be recorded. Both 6 and 12 months clinical outcomes and procedural outcomes will be assessed. Patient will be reviewed by the treating physicians before discharge and at clinic as per local practice. The primary clinical endpoint is the 12 months major adverse cardiac event (MACE), defined as a composite of death, Myocardial infraction (Q-wave and non-Q wave), emergent coronary artery bypass graft surgery, or repeat clinically driven target-lesion revascularization (TLR) by percutaneous or surgical methods. The primary procedural outcomes are device success which defined as achieving less than 50% residual stenosis after the usage of only the study device, the lesion success defined as achieving less than 50% residual stenosis of target lesion using any percutaneous method, and procedural success, defined as lesion success and no in-hospital MACE during the index admission. Categorical variables will be reported as percentages and counts, and continuous variables will be reported as means ± standard deviations. Data analysis will be performed using STATA version 15 software (College Station, Texas, USA).

Conditions

• Myocardial Infarction
• Drug-Coated Balloon

Interventions

Type	Name	Description
DEVICE	A Paclitaxel Drug-Coated Balloon	Size: 2.0mm-4.0mm x 15-30mm Coated drug: Prevail TM

Timeline

• Start date: 2022-04-29
• Primary completion: 2024-04-30
• Completion: 2024-07-31
• First posted: 2022-09-30
• Last updated: 2024-02-16

Locations

1 site across 1 country: Hong Kong