Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent (RESOLUTE-AC)

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00617084
First received: February 4, 2008
Last updated: May 27, 2014
Last verified: May 2014

February 4, 2008
May 27, 2014
April 2008
May 2010   (final data collection date for primary outcome measure)
Target Lesion Failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.
Not Provided
Complete list of historical versions of study NCT00617084 on ClinicalTrials.gov Archive Site
In-Stent Percent Diameter Stenosis [ Time Frame: 13 Months ] [ Designated as safety issue: No ]
In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.
Not Provided
Not Provided
Not Provided
 
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
RESOLUTE-III All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention

The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.

Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.

The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.

Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.

Study hypothesis: To determine whether the Zotarolimus-Eluting stent (Medtronic Endeavor-Resolute) is non-inferior to the Everolimus-eluting stent (Abbott XIENCE V) in terms of the primary endpoint at 12 months after stent implantation.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Coronary Artery Disease
  • Device: Medtronic Endeavor Resolute
    Medtronic Endeavor Resolute
    Other Name: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
  • Device: Abbott Xience V
    Abbott Xience V
    Other Name: XIENCE V Everolimus Eluting Coronary Stent System
  • Active Comparator: 1. Resolute
    Medtronic Endeavor Resolute
    Intervention: Device: Medtronic Endeavor Resolute
  • Active Comparator: 2. XIENCE V
    Abbott Xience V
    Intervention: Device: Abbott Xience V

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2292
February 2014
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Minimal age 18 years
  • Symptomatic coronary artery disease
  • Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
  • Presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
  • Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
  • Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent.

Exclusion Criteria:

  • Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
  • Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material
  • Participating in other trial before reaching primary endpoint
  • Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00617084
Version 1.2 - IP090
Yes
Medtronic Vascular
Medtronic Vascular
Medtronic Bakken Research Center
Principal Investigator: Patrick Serruys, MD Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands
Principal Investigator: Sigmund Silber, MD Kardiologische Praxis und Praxisklinik, Munich, Germany
Principal Investigator: Stephan Windecker, MD University Hospital Bern, Bern, Switzerland
Medtronic Vascular
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP