Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China
NCT ID: NCT04641468
Last Updated: 2020-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-11-01
2021-12-31
Brief Summary
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Detailed Description
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Drug coated balloon (DCB) as a new interventional therapy in recent years, has been gradually used in the treatment of primary coronary artery disease in situ. The latest international consensus on the treatment of coronary heart disease with DCB indicates that more and more clinical studies have shown the safety and effectiveness of DCB in the treatment of coronary artery disease (≥ 3.0 mm). However, there are few studies on the interventional therapy of DCB in the primary mediana type 010 or 001 left trunk end bifurcation lesions, especially the combination of "1-2mm" drug-eluting stent (DES) implantation when necessary.
The purpose of this study was to investigate the feasibility and short-term clinical efficacy of DCB combined with DES implantation in the treatment of primary mediana 010 or 001 left main bifurcation lesions, and to explore a new treatment for such lesions.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mediana 010 or 001 left main bifurcation lesion
DCB alone combined with retracted DES implantation if necessary (d-p-d strategy)
DCB
OCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary
Interventions
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DCB
OCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. There is clear evidence of myocardial ischemia, including typical ECG changes, non ST segment elevation acute coronary syndrome, ST segment elevation acute myocardial infarction, etc;
3. For mediana 010 or 001 confirmed by coronary angiography, the stenosis was more than 70% by visual inspection and less than 30% at the end of left main artery;
4. They can receive DCB treatment;
5. The reference vessel diameter was 2.00 \~ 4.00 mm;
6. To understand the potential risk of operation and have the intention of DCB treatment.
Exclusion Criteria
2. The left ventricular ejection fraction was less than 35%;
3. Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
4. Stents were implanted in the left main trunk;
5. Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
6. Severe infection;
7. Life expectancy is less than one year. All patients signed the informed consent of interventional therapy before operation, and this study was approved by hospital ethics committee.
18 Years
75 Years
ALL
No
Sponsors
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Xuzhou Third People's Hospital
OTHER
Responsible Party
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Principal Investigators
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yaojun zhang, doctor
Role: PRINCIPAL_INVESTIGATOR
Head of Cardiology Department of Xuzhou Third People's Hospital
Locations
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Xuzhou Third People's Hospital
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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fengjiao huang, master
Role: primary
References
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Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
Gruchalla KJ, Nawarskas JJ. The paclitaxel-eluting stent in percutaneous coronary intervention: part I: background and clinical comparison to bare metal stents. Cardiol Rev. 2006 Mar-Apr;14(2):88-98. doi: 10.1097/01.crd.0000200895.60631.0b.
Navarese EP, Austin D, Gurbel PA, Andreotti F, Tantry U, James S, Buffon A, Kozinski M, Obonska K, Bliden K, Jeong YH, Kubica J, Kunadian V. Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials. Clin Res Cardiol. 2013 Apr;102(4):279-87. doi: 10.1007/s00392-012-0532-3. Epub 2012 Dec 20.
Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023.
Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, Schalij MJ, Wouter Jukema J. Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J. 2010 May;31(10):1172-80. doi: 10.1093/eurheartj/ehn553. Epub 2009 Jan 21.
Chang M, Park DW. Optimal Duration of Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents: Shorter or Longer? Cardiol Ther. 2014 Dec;3(1-2):1-12. doi: 10.1007/s40119-014-0030-y. Epub 2014 Nov 1.
De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1.
Other Identifiers
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2019-02-002-K01
Identifier Type: -
Identifier Source: org_study_id