CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
primary PCI with thrombectomy +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/NCT01271361
NCT01271361Phase 2Completed
CompareCT.gov

Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study

Terumo Europe N.V.·interventional·Posted Jan 6, 2011·Updated Dec 7, 2012

In Brief

A Phase 2 clinical trial evaluating primary PCI with thrombectomy and primary PCI without thrombectomy for Coronary Artery Disease and 2 related conditions. Completed, enrolled 140 participants across 5 sites in 4 countries.

Detailed Summary

The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Myocardial Infarction, STEMI
CountriesDenmark, France, Germany, Netherlands
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2011
Enrollment StartNov 1, 2010
Primary CompletionSep 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.5 years ago

Interventions

primary PCI with thrombectomyprocedure

thrombectomy is performed before implantation of a drug eluting stent

primary PCI without thrombectomyprocedure

no thrombectomy is performed before the implantation of a drug eluting stent