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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Medtronic Endeavor Resolute

Abbott Xience V

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Drug Eluting Stents, Interventional Cardiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stiftung Inselspital, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1. Resolute

2. XIENCE V

Arm Description

Medtronic Endeavor Resolute

Abbott Xience V

Outcomes

Primary Outcome Measures

Target Lesion Failure

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

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.

Full Information

NCT ID

NCT00617084

First Posted

February 4, 2008

Last Updated

May 27, 2014

Sponsor

Medtronic Vascular

Collaborators

Medtronic Bakken Research Center

1. Study Identification

Unique Protocol Identification Number

NCT00617084

Brief Title

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

Acronym

RESOLUTE-AC

Official Title

RESOLUTE-III All-comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Vascular

Collaborators

Medtronic Bakken Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Drug Eluting Stents, Interventional Cardiology

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2292 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Resolute

Arm Type

Active Comparator

Arm Description

Medtronic Endeavor Resolute

Arm Title

2. XIENCE V

Arm Type

Active Comparator

Arm Description

Abbott Xience V

Intervention Type

Device

Intervention Name(s)

Medtronic Endeavor Resolute

Other Intervention Name(s)

Endeavor Resolute Zotarolimus-Eluting Coronary Stent System

Intervention Description

Medtronic Endeavor Resolute

Intervention Type

Device

Intervention Name(s)

Abbott Xience V

Other Intervention Name(s)

XIENCE V Everolimus Eluting Coronary Stent System

Intervention Description

Abbott Xience V

Primary Outcome Measure Information:

Title

Target Lesion Failure

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

In-Stent Percent Diameter Stenosis

Description

Time Frame

13 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Serruys, MD

Organizational Affiliation

Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sigmund Silber, MD

Organizational Affiliation

Kardiologische Praxis und Praxisklinik, Munich, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephan Windecker, MD

Organizational Affiliation

University Hospital Bern, Bern, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stiftung Inselspital, Department of Cardiology

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

26823484

Citation

Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.

Results Reference

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PubMed Identifier

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Citation

Iqbal J, Serruys PW, Silber S, Kelbaek H, Richardt G, Morel MA, Negoita M, Buszman PE, Windecker S. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015 Jun;8(6):e002230. doi: 10.1161/CIRCINTERVENTIONS.114.002230.

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PubMed Identifier

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Citation

Taniwaki M, Windecker S, Zaugg S, Stefanini GG, Baumgartner S, Zanchin T, Wenaweser P, Meier B, Juni P, Raber L. The association between in-stent neoatherosclerosis and native coronary artery disease progression: a long-term angiographic and optical coherence tomography cohort study. Eur Heart J. 2015 Aug 21;36(32):2167-76. doi: 10.1093/eurheartj/ehv227. Epub 2015 Jun 3.

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PubMed Identifier

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Campos CM, Costa F, Garcia-Garcia HM, Bourantas C, Suwannasom P, Valgimigli M, Morel MA, Windecker S, Serruys PW. Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. Circ Cardiovasc Interv. 2015 Apr;8(4):e002279. doi: 10.1161/CIRCINTERVENTIONS.114.002279.

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PubMed Identifier

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PubMed Identifier

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Citation

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PubMed Identifier

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PubMed Identifier

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PubMed Identifier

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

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