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XIENCE 28 Global Study

NCT03355742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 963

Last updated 2021-03-04

Study results available
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Summary

XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System \[EECSS\], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents

Conditions

Interventions

DEVICE

XIENCE

Subjects who received XIENCE family stent systems will be included.

DRUG

DAPT

1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Marco Valgimigli, MD · Bern University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2019-10-24
Completion
2020-04-30

Countries

  • Austria
  • Belgium
  • China
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Portugal
  • Singapore
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03355742 on ClinicalTrials.gov