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XIENCE 28 USA Study

NCT03815175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1605

Last updated 2022-05-03

Study results available
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Summary

The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate 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 and XIENCE Sierra EECSS) of coronary drug-eluting stents.

Conditions

Interventions

DEVICE

XIENCE

Subjects who received XIENCE family stent systems will be included.

DRUG

DAPT (aspirin and/or P2Y12 receptor inhibitor)

"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for \> 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Roxana Mehran, MD · Mount Sinai Medical Center,New York, NY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2020-08-14
Completion
2021-02-04
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • 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 NCT03815175 on ClinicalTrials.gov