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Clinical Trials/NCT02325817
NCT02325817CompletedNot Applicable

A Multicenter, Superior, Randomized Controlled Clinical Trial to Observe the Safety and Efficacy of Bingo Drug-eluting Balloon vs. Yinyi Balloon Dilatation Catheter in the Treatment of Patients With Bifurcation Stenosis Lesions of Coronary Artery

Yinyi(Liaoning) Biotech Co., Ltd.1 site in 1 country222 target enrollmentStarted: December 3, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
222
Locations
1
Primary Endpoint
Target lesion Stenosis (diameter, %)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or non-pregnant female ages 18-80 years old
  • •Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction
  • •Patients with bifurcation lesions of coronary artery observed by angiography.
  • •The main branch of the vessels are suitable for PCI and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation.
  • •De Novo bifurcation lesions and diameter stenosis are not less than70%;
  • •Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm
  • •Residual stenosis are not more than 50% after predilatation;
  • •Patients who understand the purpose of this trial, voluntary and sign informed consent.

Exclusion Criteria

  • •Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty
  • •Left main coronary artery lesions without protection or related bifurcation lesions
  • •Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)
  • •Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl；
  • •Patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy;
  • •Patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor)
  • •Patients whose expected lives are less than 1 year;
  • •Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.
  • •In-stent restenosis lesions
  • •Patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.

Arms & Interventions

Drug-eluting balloon

Experimental

Treat the side branch of bifurcation lesion with drug-eluting balloon

Intervention: Drug-eluting balloon (Device)

Uncoated balloon

Active Comparator

Treat the side branch of bifurcation lesion with uncoated balloon

Intervention: Uncoated ballloon (Device)

Outcomes

Primary Outcomes

Target lesion Stenosis (diameter, %)

Time Frame: 9 months

Secondary Outcomes

  • All-cause death(1, 6 and 9 months)
  • Cardiac death(1, 6 and 9 months)
  • TLR(1, 6 and 9 months)
  • TVR(1, 6 and 9 months)
  • TLF(1, 6 and 9 months)
  • MACCE(1, 6 and 9 months)
  • Non-fatal MI, thrombosis(1, 6 and 9 months)
  • Thrombosis(1, 6 and 9 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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Bingo Drug-eluting Balloon in Bifurcation | Clinical Trial