Status:
COMPLETED
Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain.
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The Redes registry is set up to document the overall clinical performance and costs of the Endeavor Resolute coronary stent in a "real life" subject population of 450 patients that require a stent in ...
Eligibility Criteria
Inclusion
- Subject is \>18 years old
- Subject has agreed to participate in the study by signing the "Patient Informed Consent" and/or has authorized the collection and disclosure of their personal health information by signing the "Patient Data Collection Form".
- There is an indication for a drug-eluting stent and a clinical decision to use Endeavor Resolute in all the lesions found.
- Subject is able and willing to co-operate and to comply with the study protocol and undergo follow-up requirements.
Exclusion
- Subject is a childbearing or breastfeeding female.
- Subject has a known hypersensitivity or allergy to acetylsalicylic acid, heparin, clopidogrel, ticlopidine, drugs such as zotarolimus, rapamycin, tacrolimus, sirolimus or other similar drugs, or any other analog or derivative drug, cobalt, chrome, nickel, molybdenum or contrast media.
- Subject has a contraindication to anticoagulants and/or antiplatelets.
- Subject's lesion might prevent proper balloon inflation during angioplasty.
- Primary or rescue angioplasty.
- Subject has one or more drug-eluting stents other than Endeavor Resolute in other lesions.
- Intention for elective treatment with other drug-eluting stent other than Endeavor Resolute.
- Current medical condition is associated with a life expectancy ≤ 12 months.
- Subject is participating in another investigational drug or device study and has not completed the follow-up required for that study at least 30 days prior to signing the consent form in this study. Subject can only be enrolled once in this study.
- Subject has a medical condition preventing follow-up as established in the protocol or limiting participation in this study.
- Subject cannot guarantee follow-up.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00850213
Start Date
February 1 2009
End Date
February 1 2011
Last Update
March 23 2017
Active Locations (6)
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1
Hospital Juan Canalejo
A Coruña, Spain
2
Hospital General de Alicante
Alicante, Spain
3
Hospital Universitari de Bellvitge
Barcelona, Spain
4
Hospital de León
León, Spain