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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Medtronic Endeavor Resolute
Device: Abbott Xience V
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: RESOLUTE-III All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2292
Study Start Date: April 2008
Study Completion Date: February 2014
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Resolute
Medtronic Endeavor Resolute
Device: Medtronic Endeavor Resolute
Medtronic Endeavor Resolute
Other Name: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System
Active Comparator: 2. XIENCE V
Abbott Xience V
Device: Abbott Xience V
Abbott Xience V
Other Name: XIENCE V Everolimus Eluting Coronary Stent System

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617084

Locations
Switzerland
Stiftung Inselspital, Department of Cardiology
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Medtronic Vascular
Medtronic Bakken Research Center
Investigators
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
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00617084     History of Changes
Other Study ID Numbers: Version 1.2 - IP090
Study First Received: February 4, 2008
Results First Received: November 22, 2010
Last Updated: May 27, 2014
Health Authority: Belgium: Institutional Review Board
Denmark: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Ireland: Medical Ethics Research Committee
Israel: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

Keywords provided by Medtronic Vascular:
Drug Eluting Stents
Interventional Cardiology

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014