Prevail Drug Balloon Study

NCT05562089 | Recruiting

• 1 other identifier: 2021.637
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• Device success

  device success which defined as achieving less than 50% residual stenosis after the usage of only the study device

  12month

• Lesion success

  the lesion success defined as achieving less than 50% residual stenosis of target lesion using any percutaneous method

  12 month

• Procedural success

  the procedural success defined as lesion success and no in-hospital MACE during the index admission

  12 month

Study Arms (1)

Prevail

EXPERIMENTAL

Device: A Paclitaxel Drug-Coated Balloon

Interventions

A Paclitaxel Drug-Coated Balloon DEVICE

Size: 2.0mm-4.0mm x 15-30mm Coated drug: Prevail TM

Prevail

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age \>18.
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment.
• 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).
• Target lesion must have a stenosis of \>50% and \<100% angiographically.
• Target lesion much have an angiographic reference vessel diameter of 2.0-4.0 mm.
• 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.
• Target lesion must have a Thrombolysis in Myocardial Infarction flow \>2 before applying DCB.

You may not qualify if:

• Known history of an allergic reaction or significant sensitivity to paclitaxel or other analogue or derivative.
• Known history of an allergic reaction or significant sensitivity to urea or its analogue or derivative.
• Pregnant or breastfeeding woman.
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

RECRUITING

Related Publications (8)

• 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.

  PMID: 26417060 RESULT

• 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 Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.

  PMID: 31561250 RESULT

• 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.

  PMID: 17098825 RESULT

• 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(6):1580-9. doi: 10.1016/s0735-1097(00)00570-2.

  PMID: 10807464 RESULT

• 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 paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14.

  PMID: 23158530 RESULT

• 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 experience from our registry. J Interv Cardiol. 2014 Aug;27(4):348-55. doi: 10.1111/joic.12129. Epub 2014 May 11.

  PMID: 24815951 RESULT

• 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 European-wide FALCON all-comers DCB Registry (FALCON Registry). EuroIntervention. 2019 Jul 20;15(4):e382-e388. doi: 10.4244/EIJ-D-18-00261.

  PMID: 29992902 RESULT

• 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 Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study. J Invasive Cardiol. 2021 Nov;33(11):E863-E869. doi: 10.25270/jic/21.00119. Epub 2021 Aug 19.

  PMID: 34433695 RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Bryan Yan

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Xu

CONTACT

35051518; danielxu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 30, 2022
• Study Start: April 29, 2022
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

HK (1)