Prevail Drug Balloon Study

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562089
• Other study ID #: 2021.637
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Daniel Xu
• Phone: 35051518
• Email: danielxu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug-Coated Balloon
• Infarction
• Myocardial Infarction

Intervention

Device:
• A Paclitaxel Drug-Coated Balloon
Size: 2.0mm-4.0mm x 15-30mm Coated drug: Prevail TM

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (8)

Basavarajaiah S, Latib A, Shannon J, Naganuma T, Sticchi A, Bertoldi L, Costopoulos C, Figini F, Carlino M, Chieffo A, Montorfano M, Colombo A. Drug-eluting balloon in the treatment of in-stent restenosis and diffuse coronary artery disease: real-world ex — View Citation

Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Gruntzig Lecture ESC 2014. Eur Heart J. 2015 Dec 14;36(47):3320-31. doi: 10.1093/eurheartj/ehv511. Epub 2015 Sep 28. — View Citation

Chien S. Mechanotransduction and endothelial cell homeostasis: the wisdom of the cell. Am J Physiol Heart Circ Physiol. 2007 Mar;292(3):H1209-24. doi: 10.1152/ajpheart.01047.2006. Epub 2006 Nov 10. — View Citation

Gyongyosi M, Yang P, Khorsand A, Glogar D. Longitudinal straightening effect of stents is an additional predictor for major adverse cardiac events. Austrian Wiktor Stent Study Group and European Paragon Stent Investigators. J Am Coll Cardiol. 2000 May;35( — View Citation

Latib A, Agostoni P, Dens J, Patterson M, Lancellotti P, Tam FCC, Schotborgh C, Kedhi E, Stella P, Shen C, Wetzels G, Testa L; PREVAIL Study Investigators. Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Ar — View Citation

Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclita — View Citation

Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and I — View Citation

Widder JD, Cortese B, Levesque S, Berliner D, Eccleshall S, Graf K, Doutrelant L, Ahmed J, Bressollette E, Zavalloni D, Piraino D, Roguin A, Scheller B, Stella PR, Bauersachs J. Coronary artery treatment with a urea-based paclitaxel-coated balloon: the Eu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event (MACE)	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
Primary	Device success	device success which defined as achieving less than 50% residual stenosis after the usage of only the study device	12month
Primary	Lesion success	the lesion success defined as achieving less than 50% residual stenosis of target lesion using any percutaneous method	12 month
Primary	Procedural success	the procedural success defined as lesion success and no in-hospital MACE during the index admission	12 month