Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00476957
First received: May 21, 2007
Last updated: February 3, 2014
Last verified: February 2014

May 21, 2007
February 3, 2014
June 2007
May 2012   (final data collection date for primary outcome measure)
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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Definite or probable stent thrombosis rate.
Not Provided
Complete list of historical versions of study NCT00476957 on ClinicalTrials.gov Archive Site
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
Not Provided
 
Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Ischemic Heart Disease
  • Device: Stent
    Stent implantation
    Other Name: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
  • Device: Stent
    Stent implantation
    Other Name: Cordis Cypher® Sirolimus-eluting Coronary Stent
  • Active Comparator: 1
    Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
    Intervention: Device: Stent
  • Active Comparator: 2
    Cordis Cypher® Sirolimus-eluting Coronary Stent
    Intervention: Device: Stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8709
May 2014
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient is > 18 years of age (or minimum age as required by local regulations).
  2. The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
  3. 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*.
  4. 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*.
  5. The patient is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria:

  1. Women with known pregnancy or who are lactating.
  2. Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
  3. Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
  4. Previous brachy-therapy.
  5. Previous implantation of a drug eluting stent.
  6. Previous implantation of a bare metal stent in the preceding year.
  7. Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
  8. Current medical condition with a life expectancy of less than 3 years.
  9. Manifest acute severe heart failure (Killip class III-IV).
  10. 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.
  11. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
  12. Patients on warfarin or similar anti-coagulant therapy.
  13. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
  14. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  15. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
  16. Transplant patients.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00476957
Version 1.0 - 12 April 2007
Yes
Medtronic Vascular
Medtronic Vascular
Medtronic Bakken Research Center
Principal Investigator: Edoardo Camenzind, MD University of Geneva, Switzerland
Principal Investigator: Laura Mauri, MD Brigham and Women's Hospital, US
Principal Investigator: William O'Neill, MD University of Miami Miller School of Medicine, US
Principal Investigator: Prof. Patrick W. Serruys, MD, PhD Erasmus MC, Rotterdam, The Netherlands
Principal Investigator: Prof. Philippe Gabriel Steg, MD, PhD Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France
Principal Investigator: William Wijns, MD, PhD O.L.V. Hospital, Aalst, Belgium
Medtronic Vascular
February 2014

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