Myocardial Infarction Clinical Trial
Official title:
Drug-Coated Balloon for the Treatment of De Novo and Restenotic Coronary Artery Lesion: a Prospective Observational Study
NCT number | NCT05562089 |
Other study ID # | 2021.637 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 29, 2022 |
Est. completion date | July 31, 2024 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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
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 |
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