Prevail Drug Balloon Study

Last updated: February 15, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Congestive Heart Failure

Coronary Artery Disease

Treatment

A Paclitaxel Drug-Coated Balloon

Clinical Study ID

NCT05562089
2021.637
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject age >18.
  2. Subject (or legal guardian) understands the trial requirements and treatmentprocedures and provides written informed consent prior to any trial-specific tests ortreatment.
  3. Indication for a percutaneous intervention in native epicardial arteries or bypassgraft including patients with stable coronary artery disease and acute coronarysyndromes (non- ST-elevated myocardial infarction and ST-elevation myocardialinfarction).
  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 visualestimate 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 beforeapplying DCB.

Exclusion

Exclusion Criteria:

  1. Known history of an allergic reaction or significant sensitivity to paclitaxel orother analogue or derivative.
  2. Known history of an allergic reaction or significant sensitivity to urea or itsanalogue or derivative.
  3. Pregnant or breastfeeding woman.
  4. Currently participating in an investigational drug or another device study that hasnot completed the primary end point or that clinically interferes with the currentstudy endpoints.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: A Paclitaxel Drug-Coated Balloon
Phase:
Study Start date:
April 29, 2022
Estimated Completion Date:
July 31, 2024

Study 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).

Connect with a study center

  • The Chinese University of Hong Kong

    Shatin, 999077
    Hong Kong

    Active - Recruiting

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