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

D

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

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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