Absorb GT1 Japan PMS

Abbott

Status: Completed

Conditions: Coronary Artery Occlusion; Coronary Artery Disease; Ischemic Heart Disease; Myocardial Ischemia; Angina Pectoris

Treatments: Device: ABSORB GT1 BVS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03409731

16-310

Details and patient eligibility

About

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

Enrollment: 135 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• General Percutaneous coronary intervention (PCI) population.

Exclusion criteria

• No specific exclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

135 participants in 1 patient group

Absorb GT1 BVS

Other group

Description:

Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.

Treatment:

Device: ABSORB GT1 BVS