NCT02325817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

December 20, 2014

Last Update Submit

August 23, 2017

Conditions

Bifurcation LesionsDrug Eluting Balloon

Keywords

Bifurcation Lesionsdrug eluting balloonpaclitaxeldrug coated balloon

Outcome Measures

Primary Outcomes (1)

  • Target lesion Stenosis (diameter, %)

    9 months

Secondary Outcomes (8)

  • TLR

    1, 6 and 9 months

  • TVR

    1, 6 and 9 months

  • TLF

    1, 6 and 9 months

  • MACCE

    1, 6 and 9 months

  • All-cause death

    1, 6 and 9 months

  • +3 more secondary outcomes

Study Arms (2)

Drug-eluting balloon

EXPERIMENTAL

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

Device: Drug-eluting balloon

Uncoated balloon

ACTIVE COMPARATOR

Treat the side branch of bifurcation lesion with uncoated balloon

Device: Uncoated ballloon

Interventions

Drug-eluting balloonDEVICE

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

Drug-eluting balloon
Uncoated ballloonDEVICE

Treat the side branch of bifurcation lesion with uncoated balloon

Uncoated balloon

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Location

Related Publications (1)

  • Jing QM, Zhao X, Han YL, Gao LL, Zheng Y, Li ZQ, Yang P, Cong HL, Gao CY, Jiang TM, Li H, Li JX, Wang DM, Wang G, Cong ZC, Zhang Z. A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China. Chin Med J (Engl). 2020 Apr 20;133(8):899-908. doi: 10.1097/CM9.0000000000000743.

    PMID: 32265425DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2014

First Posted

December 25, 2014

Study Start

December 3, 2014

Primary Completion

November 29, 2016

Study Completion

January 13, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

CN(1)