Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain. (REDES)

Medtronic

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Endeavor Resolute Stent

Study type: Observational

Funder types: Industry

Identifiers

NCT00850213

MDT-REDES1.7

Details and patient eligibility

About

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 Spain. Primary objectives are the overall cost for patients during initial hospitalization and at 1-year follow-up, as well as the MACE rate at 30 days, 6 months and 12 months post procedure.

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

448 participants in 1 patient group

Endeavor Resolute Stent

Description:

Patients implanted with the Medtronic Endeavor Resolute stent

Treatment:

Device: Endeavor Resolute Stent