Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China

NCT04641468 | Unknown DMC

• 1 other identifier: 2019-02-002-K01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.

Conditions

Coronary Diseases; Left Main Coronary Artery Disease; Bifurcation Lesions

Keywords

DCB; left main trunk; Bifurcation lesions

Outcome Measures

Primary Outcomes (1)

• The patients were followed up for 12 months to observe the major adverse cardiac events (MACE)

  There were three endpoints: cardiovascular death, myocardial infarction and stroke

  12 months after operation

Secondary Outcomes (2)

• Incidence of target lesion revascularization

  12 months after operation

• All revascularization rates

  12 months after operation

Study Arms (1)

Mediana 010 or 001 left main bifurcation lesion

OTHER

DCB alone combined with retracted DES implantation if necessary (d-p-d strategy)

Procedure: DCB

Interventions

DCB PROCEDURE

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

Also known as: optical coherence tomography

Mediana 010 or 001 left main bifurcation lesion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non pregnant women aged 18-75 years old;
• 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;
• 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;
• They can receive DCB treatment;
• The reference vessel diameter was 2.00 \~ 4.00 mm;
• To understand the potential risk of operation and have the intention of DCB treatment.

You may not qualify if:

• Hemodynamic instability, unable to tolerate surgery;
• The left ventricular ejection fraction was less than 35%;
• Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
• Stents were implanted in the left main trunk;
• Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
• Severe infection;
• 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.

Sponsors & Collaborators

• Xuzhou Third People's Hospital: lead

Study Sites (1)

Xuzhou Third People's Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 8041414 RESULT

• 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.

  PMID: 8041413 RESULT

• 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.

  PMID: 16493246 RESULT

• 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.

  PMID: 23262495 RESULT

• 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.

  PMID: 17145250 RESULT

• 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.

  PMID: 17869634 RESULT

• 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.

  PMID: 19158118 RESULT

• 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.

  PMID: 25367504 RESULT

• 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.

  PMID: 25176289 RESULT

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• yaojun zhang, doctor

  Head of Cardiology Department of Xuzhou Third People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

fengjiao huang, Master

CONTACT

+86-13685102194; 13685102194@163.com

zheng li, Master

CONTACT

+86-13813297135; 13813297135@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)