Status:
COMPLETED
PROTECT Continued Access Post Marketing Surveillance Trial
Lead Sponsor:
Medtronic Vascular
Conditions:
Coronary Artery Disease, Autosomal Dominant, 1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 amende...
Detailed Description
This was a prospective, multicenter, non-randomized, single-arm, open-label post market surveillance study designed to expand safety information in patients treated with the Endeavor® Zotarolimus Elut...
Eligibility Criteria
Inclusion
- Patient is \> 18 years of age (or minimum age as required by local regulations).
- 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".
- 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.
- 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
- 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 brachytherapy.
- 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.
- 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.
- 16 Transplant patients.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
1018 Patients enrolled
Trial Details
Trial ID
NCT00846846
Start Date
January 1 2009
End Date
March 1 2015
Last Update
May 4 2015
Active Locations (1)
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1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605