Back to resultsRandomized Study Comparing Endeavor With Cypher Stents (PROTECT) (PROTECT)
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Stent
Stent
Sponsored by
About this trial
This is an interventional health services research trial for Ischemic Heart Disease focused on measuring Drug Eluting Stents, Interventional Cardiology
Eligibility Criteria
Inclusion Criteria:
- Patient is > 18 years of age (or minimum age as required by local regulations).
- The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
- All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary Stent*.
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting Coronary Stent. Patients should qualify for both systems before randomization*.
- The patient is willing and able to cooperate with study procedures and required follow up visits.
Exclusion Criteria:
- Women with known pregnancy or who are lactating.
- Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
- Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
- Previous brachy-therapy.
- Previous implantation of a drug eluting stent.
- Previous implantation of a bare metal stent in the preceding year.
- Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
- Current medical condition with a life expectancy of less than 3 years.
- Manifest acute severe heart failure (Killip class III-IV).
- The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.
- Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
- Patients on warfarin or similar anti-coagulant therapy.
- Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- Transplant patients.
Sites / Locations
- 196 enrolling sites Worldwide
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Cordis Cypher® Sirolimus-eluting Coronary Stent
Outcomes
Primary Outcome Measures
To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation
Definite or probable stent thrombosis rate.
Secondary Outcome Measures
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions
Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions
Full Information
NCT ID
NCT00476957
First Posted
May 21, 2007
Last Updated
November 3, 2014
Sponsor
Medtronic Vascular
Collaborators
Medtronic Bakken Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00476957
Brief Title
Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
Acronym
PROTECT
Official Title
PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 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 PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions.
Study Stents:
Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model
Primary Objective: To compare overall stent thrombosis rate of the Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation
Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation.
To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart 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
Outcomes Assessor
Allocation
Randomized
Enrollment
8709 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cordis Cypher® Sirolimus-eluting Coronary Stent
Intervention Type
Device
Intervention Name(s)
Stent
Other Intervention Name(s)
Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Intervention Description
Stent implantation
Intervention Type
Device
Intervention Name(s)
Stent
Other Intervention Name(s)
Cordis Cypher® Sirolimus-eluting Coronary Stent
Intervention Description
Stent implantation
Primary Outcome Measure Information:
Title
To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation
Description
Definite or probable stent thrombosis rate.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions
Description
Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is > 18 years of age (or minimum age as required by local regulations).
The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary Stent*.
Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting Coronary Stent. Patients should qualify for both systems before randomization*.
The patient is willing and able to cooperate with study procedures and required follow up visits.
Exclusion Criteria:
Women with known pregnancy or who are lactating.
Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
Previous brachy-therapy.
Previous implantation of a drug eluting stent.
Previous implantation of a bare metal stent in the preceding year.
Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
Current medical condition with a life expectancy of less than 3 years.
Manifest acute severe heart failure (Killip class III-IV).
The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.
Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
Patients on warfarin or similar anti-coagulant therapy.
Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
Transplant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo Camenzind, MD
Organizational Affiliation
University of Geneva, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Mauri, MD
Organizational Affiliation
Brigham and Women's Hospital, US
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William O'Neill, MD
Organizational Affiliation
University of Miami Miller School of Medicine, US
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Patrick W. Serruys, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Philippe Gabriel Steg, MD, PhD
Organizational Affiliation
Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Wijns, MD, PhD
Organizational Affiliation
O.L.V. Hospital, Aalst, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
196 enrolling sites Worldwide
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19958855
Citation
Camenzind E, Wijns W, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A, O'Neill W, Serruys PW, Jorissen B, Steg PG; PROTECT Steering Committee and Investigators. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am Heart J. 2009 Dec;158(6):902-909.e5. doi: 10.1016/j.ahj.2009.10.002.
Results Reference
background
PubMed Identifier
22951082
Citation
Camenzind E, Wijns W, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Boersma E, Vranckx P, McFadden E, Serruys PW, O'Neil WW, Jorissen B, Van Leeuwen F, Steg PG; PROTECT Steering Committee and Investigators. Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. Lancet. 2012 Oct 20;380(9851):1396-405. doi: 10.1016/S0140-6736(12)61336-1. Epub 2012 Aug 27.
Results Reference
result
PubMed Identifier
28335893
Citation
Roguin A, Camenzind E, Kerner A, Beyar R, Boersma E, Mauri L, Steg PG, Wijns W. Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial. JACC Cardiovasc Interv. 2017 Mar 27;10(6):548-556. doi: 10.1016/j.jcin.2016.12.028.
Results Reference
derived
PubMed Identifier
25910523
Citation
Secemsky EA, Matteau A, Yeh RW, Steg PG, Camenzind E, Wijns W, McFadden E, Mauri L; PROTECT Trial Investigators. Comparison of Short- and Long-Term Cardiac Mortality in Early Versus Late Stent Thrombosis (from Pooled PROTECT Trials). Am J Cardiol. 2015 Jun 15;115(12):1678-84. doi: 10.1016/j.amjcard.2015.03.010. Epub 2015 Mar 23.
Results Reference
derived
PubMed Identifier
25106761
Citation
Wijns W, Steg PG, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Lipsic E, Alamgir F, Rademaker-Havinga T, Boersma E, Radke P, van Leeuwen F, Camenzind E; PROTECT Steering Committee and Investigators. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial. Eur Heart J. 2014 Oct 21;35(40):2812-20. doi: 10.1093/eurheartj/ehu318. Epub 2014 Aug 8.
Results Reference
derived
PubMed Identifier
24627416
Citation
Camenzind E, Boersma E, Wijns W, Mauri L, Rademaker-Havinga T, Ordoubadi FF, Suttorp MJ, Al Kurdi M, Steg PG; PROTECT Steering Committee and Investigators. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type. Eur Heart J. 2014 Aug 1;35(29):1932-48. doi: 10.1093/eurheartj/ehu084. Epub 2014 Mar 13.
Results Reference
derived
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Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
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