Prevail Drug Balloon Study

February 15, 2024 updated by: Professor Bryan Ping Yen YAN, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Shatin, Hong Kong, 999077
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevail
Device: A Paclitaxel Drug-Coated Balloon
Size: 2.0mm-4.0mm x 15-30mm Coated drug: Prevail TM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event (MACE)
Time Frame: 12 month
Major adverse cardiac events (MACE) were defined as the composite of total death; myocardial infraction; stroke, hospitalization because of heart failure; and revascularization, including percutaneous coronary intervention, and coronary artery bypass graft
12 month
Device success
Time Frame: 12month
device success which defined as achieving less than 50% residual stenosis after the usage of only the study device
12month
Lesion success
Time Frame: 12 month
the lesion success defined as achieving less than 50% residual stenosis of target lesion using any percutaneous method
12 month
Procedural success
Time Frame: 12 month
the procedural success defined as lesion success and no in-hospital MACE during the index admission
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Bryan Yan, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.637

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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