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Clinical Trials/NCT01147237
NCT01147237
Unknown
Phase 4

A Multi Center Registry to Evaluate Multiple Stenting Using by Everolimus-eluting Stents for Treatment of Long Coronary Artery Disease

Society for Advancement of Coronary Intervention Research31 sites in 1 country450 target enrollmentFebruary 2010
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ConditionsLong Coronary Artery Disease

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Long Coronary Artery Disease
Sponsor
Society for Advancement of Coronary Intervention Research
Enrollment
450
Locations
31
Primary Endpoint
Target lesion revascularization rate
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The utilization of everolimus-eluting coronary stents in a coronary artery diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of multiple everolimus-eluting coronary stent implantation in long (>30mm) coronary lesions.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
December 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Society for Advancement of Coronary Intervention Research

Eligibility Criteria

Inclusion Criteria

  • •Age ≥20 years and are able to undergo CABG
  • •Females who are not pregnant
  • •Patients who present with angina symptoms or myocardial ischemia
  • •Patients available for post-procedural observation and coronary angiography at 24 months
  • •Patients who have signed patient informed consent
  • •Lesion length is more than 30mm
  • •De novo lesion or non-stented restenosed lesion

Exclusion Criteria

  • •Patients contraindicated for antiplatelet therapy or anticoagulant therapy
  • •Patients with significant allergic reaction to contrast medium
  • •Chronic total occlusion
  • •Lesion with TIMI0
  • •Patients with chronic renal failure (SCr\>3.0mg/dl) -

Outcomes

Primary Outcomes

Target lesion revascularization rate

Time Frame: 1 year

Secondary Outcomes

  • Technical success(Initial)
  • Angiographic restenosis(9 months)
  • Target vessel revascularization(2 year)
  • Target lesion revascularization(2 year)
  • Incidences of acute, sub acute, and late stent thrombosis(2 year)
  • Incidence of MACCE(2 year)

Study Sites (31)

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