Bingo Drug-Coated Balloon in Real World

NCT04234893 | Completed DMC

• 1 other identifier: BEYOND Registry
• Study Type: observational
• Target: 805
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.

Conditions

Coronary Stenosis; Drug-coated Balloon; De Novo Stenosis; Coronary Artery Disease in Transplanted Heart Accelerated

Keywords

Coronary Stenosis; Percutaneous Coronary Intervention; Drug-coated Balloon; Drug eluting Balloon; Paclitaxel; De novo; Bifurcation; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization

  12 months

Secondary Outcomes (7)

• device success

  immediately after the procedure

• lesion success

  immediately after the procedure

• clinical success

  immediately after the procedure， up to 7 days

• rate of Target lesion revascularization

  1, 6, 12 and 24 months

• Target lesion failure

  1, 6, 12 and 24 months

Study Arms (1)

Drug-coated balloon

The Patients who treated with Bingo drug-coated balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PCI with Bingo drug-coated balloon

You may qualify if:

• Age 18 or older, regardless of gender;
• Patients suitable for PCI with paclitaxel drug-coated balloon;
• Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.

You may not qualify if:

• Contraindications to PCI;
• In-stent restenosis;
• Life expectation less than 1 year;
• Patients not suitable for enrollment considered by investigator.
• \. Target lesion with the following conditions after pre-dilatation:
• Residual stenosis larger than 30% ;
• TIMI flow grade less than 3;
• Type C-F dissection (NHLBI grade).

Sponsors & Collaborators

• Yinyi(Liaoning) Biotech Co., Ltd.: lead

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Jian-an Wang, MD, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 21, 2020
• Study Start: June 3, 2019
• Primary Completion: June 4, 2021
• Study Completion: May 4, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CN (1)