Clinical trial NCT00850213: Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain.
Official title: Registro Redes - Evaluación Del Comportamiento clínico y Del Coste Del Stent Coronario Endeavor Resolute de Medtronic "en el Mundo Real" en España
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2009-02-24
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an indication for an Endeavor Resolute coronary stent. The study will include all consecutive patients who are appropriate candidates for at least one Endeavor Resolute stent in at least one target lesion after angiography.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall patient cost
timeFrame: During initial hospitalization and at 12 month follow-up
measure: Number of major adverse cardiac events (MACE)
timeFrame: 30 days, 6 months and 1 year
Secondary outcomes:
measure: Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible)
timeFrame: 12 Months
measure: Target Lesion Revascularization (TLR)
timeFrame: 12 Months
measure: Procedure, device and lesion success rate
timeFrame: 30 Days
Other outcomes:
Locations:
city: A Coruna
country: Spain
facility: Hospital Juan Canalejo
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Leon
country: Spain
facility: Hospital de León
city: Malaga
country: Spain
facility: Hospital Cínico Universitario de Málaga
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
affiliation: Hospital Virgen de la Salud
name: José Moreu Burgos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: