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: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Device: Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Definite or probable stent thrombosis rate.


Secondary Outcome Measures:
  • 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


Enrollment: 8709
Study Start Date: June 2007
Estimated Study Completion Date: June 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Device: Stent
Stent implantation
Other Name: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Active Comparator: 2
Cordis Cypher® Sirolimus-eluting Coronary Stent
Device: Stent
Stent implantation
Other Name: Cordis Cypher® Sirolimus-eluting Coronary Stent

  Eligibility

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

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.
  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: NCT00476957

Locations
Netherlands
196 enrolling sites Worldwide
Maastricht, Netherlands
Sponsors and Collaborators
Medtronic Vascular
Medtronic Bakken Research Center
Investigators
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
  More Information

Publications:
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00476957     History of Changes
Other Study ID Numbers: Version 1.0 - 12 April 2007
Study First Received: May 21, 2007
Results First Received: September 17, 2013
Last Updated: May 27, 2014
Health Authority: Argentina: Human Research Bioethics Committee
Australia: Human Research Ethics Committee
Austria: Ethikkommission
Belgium: Institutional Review Board
Brazil: National Committee of Ethics in Research
Canada: Canadian Institutes of Health Research
China: Ethics Committee
Finland: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Greece: Ethics Committee
Hong Kong: Ethics Committee
India: Institutional Review Board
Ireland: Medical Ethics Research Committee
Israel: Ethics Commission
Italy: Ethics Committee
Italy: Ministry of Health
Jordan: Ethical Committee
Netherlands: Medical Ethics Review Committee (METC)
New Zealand: Institutional Review Board
Norway:National Committee for Medical and Health Research Ethics
South Africa: National Health Research Ethics Council
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
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
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014