Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Intervention: Stent; Stent
Intervention description: Stent implantation; Stent implantation
Intervention MeSH terms: Sirolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 8709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Eluting Stents; Interventional Cardiology

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.
    

Eligibility 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.