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Jailed-balloon Technique in Coronary Bifurcation Lesion PCI

China410 participantsStarted 2014-10

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years and ≤75 years;
✓. De novo Medina 1,1,1 coronary bifurcation with a main branch(MB) \>2.5mm while side branch \<2.5mm and \>1.5mm;
✓. Only one bifurcation lesion need to be treated in one vessel;
✓. 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%;
✓. Signed consent is obtained.

Exclusion criteria

✕. Left ventricular ejection fraction(LVEF) less than 30%;
✕. Hemodynamic instability or cardiac shock;
✕. Myopathy or muscular injury with elevation of creatine kinase to more than 3mg/dL;
✕. Tumor with expected survival less than 1 year;
✕. Autoimmune disease;
✕. Active gastrointestinal bleeding or any contraindication for dual antiplatelet therapy;
✕. Acute coronary syndrome require emergency PCI;
✕. Coronary bifurcation need to be treated with two-stent strategy;

What they're measuring

Side branch(SB) loss and PCI related myocardial infarction

Timeframe: Within 48 hours after PCI

Trial details

NCT IDNCT02167230

SponsorGuangdong Provincial People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

Contact for this trial

Pengcheng He, Doctor

86-20-83827812 he_peng_cheng@aliyun.com

View on ClinicalTrials.gov More Coronary Artery Disease trials