Myocardial InfarctionNCT05562089
Prevail Drug Balloon Study
A study testing A Paclitaxel Drug-Coated Balloon in people with Myocardial Infarction and Drug-Coated Balloon, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Infarction, Drug-Coated Balloon
- What is being tested?
- A Paclitaxel Drug-Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Apr 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Shatin, 999077
Daniel Xu, 35051518 ext. 1518, danielxu@cuhk.edu.hk
About this study
Official title: 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.
Read the 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).
- Conditions
- Myocardial Infarction, Drug-Coated Balloon
- Being tested
- A Paclitaxel Drug-Coated Balloon
- Keywords
- Drug-Coated Balloon, De Novo, Restenotic Coronary Artery Lesion, major adverse cardiac event, target-lesion revascularization, Myocardial infraction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Paclitaxel Drug-Coated BalloonDevice
Size: 2.0mm-4.0mm x 15-30mm Coated drug: Prevail TM
| Study group | Role | What they receive |
|---|---|---|
| Prevail | Experimental | Not described Receives: Device: A Paclitaxel Drug-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Device success
device success which defined as achieving less than 50% residual stenosis after the usage of only the study device
Measured: 12month
Lesion success
the lesion success defined as achieving less than 50% residual stenosis of target lesion using any percutaneous method
Measured: 12 month
Procedural success
the procedural success defined as lesion success and no in-hospital MACE during the index admission
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start29 Apr 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Bryan Yan, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562089
- Sponsor's protocol ID
- 2021.637
- Status last verified
- Feb 2024
- First submitted
- 20 Sep 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26417060Stone 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.
PubMed 31561250Chien 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.
PubMed 17098825Gyongyosi 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.
PubMed 10807464Latib 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.
PubMed 23158530Basavarajaiah 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.
PubMed 24815951Widder 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.
PubMed 29992902Latib 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.
PubMed 34433695
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon for the Treatment of De Novo and Restenotic Coronary Artery Lesion: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05562089
- Acronym / sponsor ID
- 2021.637
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevail | Experimental | Device: A Paclitaxel Drug-Coated Balloon |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Paclitaxel Drug-Coated BalloonSize: 2.0mm-4.0mm x 15-30mm Coated drug: Prevail TM | Device | Prevail |
Primary outcome
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
Device success
Time frame: 12month
device success which defined as achieving less than 50% residual stenosis after the usage of only the study device
Lesion success
Time frame: 12 month
the lesion success defined as achieving less than 50% residual stenosis of target lesion using any percutaneous method
Procedural success
Time frame: 12 month
the procedural success defined as lesion success and no in-hospital MACE during the index admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Results publication: PubMed 26417060Byrne 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.
- Results publication: PubMed 31561250Stone 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.
- Results publication: PubMed 17098825Chien 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.
- Results publication: PubMed 10807464Gyongyosi 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.
- Results publication: PubMed 23158530Latib 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.
- Results publication: PubMed 24815951Basavarajaiah 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.
- Results publication: PubMed 29992902Widder 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.
- Results publication: PubMed 34433695Latib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Yan principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Paclitaxel Drug-Coated Balloon in people with Myocardial Infarction and Drug-Coated Balloon, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Xu (35051518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (MACE) (time frame: 12 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562089, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.