Clinical trial NCT02167230: Jailed-balloon Technique in Coronary Bifurcation Lesion PCI
Official title: Effect of Jailed-Balloon Technique in Percutaneous Coronary Intervention for Non-Left Main Coronary Bifurcation Lesions: A Prospective, Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Percutaneous Coronary Intervention
Bifurcation
Jailed-balloon technique
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen People's Hospital
name: Kashgar 1st People's Hospital
First posted: 2014-06-19
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).

Detailed description: 1. Objective: To compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
2. Background: Solid evidence is scant to compare the protective effect between JBT and JWT during PCI for non-left main coronary bifurcation lesions.
3. Study design: This is a multi-center, prospective, randomized study.
4. Methods

4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.

4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) \>2.5mm while side branch \<2.5mm and \>1.5mm;
3. Only one bifurcation lesion need to be treated in one vessel;
4. The target lesion in MB has stenosis more than 75% or fractional flow reserve(FFR) less than 0.75 and the stenosis in SB ostium is more than 50%;
5. Signed consent is obtained.

Exclusion Criteria:

1. Left ventricular ejection fraction(LVEF) less than 30%;
2. Hemodynamic instability or cardiac shock;
3. Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
4. Tumor with expected survival less than 1 year;
5. Autoimmune disease;
6. Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
7. Acute coronary syndrome require emergency PCI;
8. Coronary bifurcation need to be treated with two-stent strategy;
9. Not suitable for drug-eluting stent(DES) implantation;
10. Mental disorder or alcohol dependence;
11. PCI or coronary artery bypass graft (CABG) within 6 months before enrollment;
12. Target lesion is in-stent restenosis;
13. Women in gestation period or lactation period or human chorionic gonadotropin (HCG) urine test positive.

Primary outcomes:
measure: Side branch(SB) loss and PCI related myocardial infarction
timeFrame: Within 48 hours after PCI
Secondary outcomes:
measure: Major adverse cardiovascular events(MACEs)
timeFrame: Within 1 year after PCI
measure: PCI related complication
timeFrame: Immediately after PCI
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Kashgar
country: China
facility: Kashgar District 1st People's Hospital
state: Xinjiang
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Jiyan Chen, Doctor
role: STUDY_CHAIR
affiliation: Guangdong Provincial People's Hospital
name: Jianfang Luo, Doctor
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Pengcheng He, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.
citation: Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv. 2008 Jun;1(3):218-26. doi: 10.1016/j.jcin.2007.12.008.
citation: Depta JP, Patel Y, Patel JS, Novak E, Yeung M, Zajarias A, Kurz HI, Lasala JM, Bach RG, Singh J. Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E637-46. doi: 10.1002/ccd.24778. Epub 2013 Jul 30.
citation: Colombo F, Biondi-Zoccai G, Infantino V, Omede P, Moretti C, Sciuto F, Siliquini R, Chiado S, Trevi GP, Sheiban I. A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions. Acta Cardiol. 2009 Oct;64(5):583-8. doi: 10.2143/AC.64.5.2042686.
citation: Singh J, Patel Y, Depta JP, Mathews SJ, Cyrus T, Zajarias A, Kurz HI, Lasala JM, Bach RG. A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique". J Interv Cardiol. 2012 Jun;25(3):289-96. doi: 10.1111/j.1540-8183.2011.00716.x. Epub 2012 Feb 26.