CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,079 enrolled
Drug / intervention
PCI with IVUS guidance +1 moreprocedure
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/NCT01308281
NCT01308281N/ACompleted
CompareCT.gov

Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)

Yonsei University·interventional·Posted Mar 4, 2011·Updated Jul 27, 2016

In Brief

A clinical study evaluating PCI with IVUS guidance and PCI without IVUS guidance for Coronary Artery Disease. Completed, enrolled 1,079 participants across 1 site.

Detailed Summary

This study is designed as a prospective, randomized, multi-center trial to demonstrate an inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting stents(EES) at long lesions(\> 28 mm) in clinical outcomes at 12 months as a primary objective and safety of 6- month dual antiplatelet therapy following EES implantation in comparison with a 12-month dual antiplatelet therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2011
Enrollment StartOct 1, 2010
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.3 years ago

Interventions

PCI with IVUS guidanceprocedure

Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.

PCI without IVUS guidanceprocedure

Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.