Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Routine Clinical Practice (IRIS BVS)

Duk-Woo Park, MD

Status: Terminated

Conditions: Coronary Artery Disease; Arterial Occlusive Diseases; Cardiovascular Diseases; Coronary Disease

Treatments: Device: Bioresorbable Vascular Scaffold

Study type: Observational

Funder types: Other

Identifiers

NCT02622100

AMCCV2015-11

Details and patient eligibility

About

The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold compared to other (drug eluting stents) DES.

Enrollment: 629 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 19 and more
• Intervention with Bioresorbable Vascular Scaffold
• Agreed with written informed consent form

Exclusion criteria

• Bypass graft surgery (CABG) recommended
• Lesion with previous bypass graft surgery (CABG)
• Severe calcification and/or severe tortuosity
• Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
• Life expectancy of 1year and under
• Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
• Cardiac shock

Trial design

629 participants in 1 patient group

Bioresorbable Vascular Scaffold

Treatment:

Device: Bioresorbable Vascular Scaffold