PROTECT Continued Access Post Marketing Surveillance Trial
Condition: Coronary Artery Disease, Autosomal Dominant, 1
MeSH terms: Coronary Artery Disease
Intervention: Endeavor® Zotarolimus Eluting Coronary Stent System
Intervention description: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1018.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In order to expand safety information in patients treated with the Endeavor Drug Eluting
      Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT
      Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA").
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is > 18 years of age (or minimum age as required by local regulations).

          2. The patient or patient's legal representative 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.

          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. Please check the
             'Instructions for Use' that comes with the product. Please be aware that the
             'Instructions for Use' may be subject to change during the course of the study.

        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 brachytherapy.

          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.

         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.