Bingo Drug-Coated Balloon in Real World

Yinyi Biotech

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04234893

BEYOND Registry

Details and patient eligibility

About

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

Enrollment: 805 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

General exclusion criteria

1. Contraindications to PCI;
2. In-stent restenosis;
3. Life expectation less than 1 year;
4. Patients not suitable for enrollment considered by investigator.

Angiographic exclusion criteria:

1. Target lesion with the following conditions after pre-dilatation:

2. Residual stenosis larger than 30% ;

3. TIMI flow grade less than 3;

4. Type C-F dissection (NHLBI grade).

Trial design

805 participants in 1 patient group

Drug-coated balloon

Description:

The Patients who treated with Bingo drug-coated balloon