Bingo Drug-eluting Balloon in Bifurcation

Bifurcation Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325817
• Other study ID #: BEYOND
• Status: Completed
• Phase: N/A
• First received: December 20, 2014
• Last updated: August 23, 2017
• Start date: December 3, 2014
• Est. completion date: January 13, 2017

Study information

• Verified date: August 2017
• Source: Liaoning Biomedical Materials R&D Center Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: January 13, 2017
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or non-pregnant female ages 18-80 years old

2. Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction

3. Patients with bifurcation lesions of coronary artery observed by angiography.

4. 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.

5. De Novo bifurcation lesions and diameter stenosis are not less than70%;

6. Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm

7. Residual stenosis are not more than 50% after predilatation;

8. Patients who understand the purpose of this trial, voluntary and sign informed consent.

Exclusion Criteria:

1. Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty

2. Left main coronary artery lesions without protection or related bifurcation lesions

3. Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)

4. Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl;

5. 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;

6. 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)

7. Patients whose expected lives are less than 1 year;

8. Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.

9. In-stent restenosis lesions

10. 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.

Related Conditions & MeSH terms

• Bifurcation Lesions
• Drug Eluting Balloon

Intervention

Device:
• Drug-eluting balloon
Treat the side branch of bifurcation lesion with drug-eluting balloon
• Uncoated ballloon
Treat the side branch of bifurcation lesion with uncoated balloon

Locations

Country	Name	City	State
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Liaoning Biomedical Materials R&D Center Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion Stenosis (diameter, %)		9 months
Secondary	TLR		1, 6 and 9 months
Secondary	TVR		1, 6 and 9 months
Secondary	TLF	cardiac death, target vessel MI, TLR	1, 6 and 9 months
Secondary	MACCE	all-cause death, MI, stroke and TVR	1, 6 and 9 months
Secondary	All-cause death		1, 6 and 9 months
Secondary	Cardiac death		1, 6 and 9 months
Secondary	Non-fatal MI, thrombosis		1, 6 and 9 months
Secondary	Thrombosis		1, 6 and 9 months