CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 963 enrolled
Drug / intervention
DAPT +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03355742
NCT03355742N/ACompleted
CompareCT.gov

XIENCE 28 Global Study

Abbott Medical Devices·interventional·Posted Nov 28, 2017·Updated Mar 4, 2021

In Brief

A clinical study evaluating XIENCE and DAPT for Bleeding Disorder and 8 related conditions. Completed, enrolled 963 participants across 52 sites in 13 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic, Hematological Disease, Thrombocytopenia, Coagulation Disorder, Anemia, Renal Insufficiency, Coronary Artery Disease
CountriesAustria, Belgium, China, Germany, Hong Kong, Italy, Netherlands, Portugal, Singapore, Spain, Switzerland, Taiwan, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 28, 2017
Enrollment StartFeb 9, 2018
Primary CompletionOct 24, 2019
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.6 years ago

Interventions

XIENCEdevice

Subjects who received XIENCE family stent systems will be included.

DAPTdrug

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