Clinical trial NCT05562089: Prevail Drug Balloon Study
Official title: Drug-Coated Balloon for the Treatment of De Novo and Restenotic Coronary Artery Lesion: a Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Drug-Coated Balloon
Keywords: Drug-Coated Balloon
De Novo
Restenotic Coronary Artery Lesion
major adverse cardiac event
target-lesion revascularization
Myocardial infraction
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

Eligibility criteria: Inclusion Criteria:

1. Subject age \>18.
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.
3. Indication for a percutaneous intervention in native epicardial arteries or bypass graft including patients with stable coronary artery disease and acute coronary syndromes (non- ST-elevated myocardial infarction and ST-elevation myocardial infarction).
4. Target lesion must have a stenosis of \>50% and \<100% angiographically.
5. Target lesion much have an angiographic reference vessel diameter of 2.0-4.0 mm.
6. Successful predilatation of the target lesions as defined by angiographic visual estimate of \<30% residual stenosis without major (defined as \>NHLBI grade B) flow-limiting dissection.
7. Target lesion must have a Thrombolysis in Myocardial Infarction flow \>2 before applying DCB.

Exclusion Criteria:

1. Known history of an allergic reaction or significant sensitivity to paclitaxel or other analogue or derivative.
2. Known history of an allergic reaction or significant sensitivity to urea or its analogue or derivative.
3. Pregnant or breastfeeding woman.
4. Currently participating in an investigational drug or another device study that has not completed the primary end point or that clinically interferes with the current study endpoints.

Primary outcomes:
measure: Major adverse cardiac event (MACE)
timeFrame: 12 month
measure: Device success
timeFrame: 12month
measure: Lesion success
timeFrame: 12 month
measure: Procedural success
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Bryan Yan
role: PRINCIPAL_INVESTIGATOR
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