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

Registro Redes - Evaluación Del Comportamiento clínico y Del Coste Del Stent Coronario Endeavor Resolute de Medtronic "en el Mundo Real" en España

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Endeavor Resolute Stent

• Study Type: Observational
• Enrollment (Actual): 448

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain
    • Hospital Juan Canalejo
  • Alicante, Spain
    • Hospital General de Alicante
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Leon, Spain
    • Hospital de Leon
  • Malaga, Spain
    • Hospital Cínico Universitario de Málaga
  • Toledo, Spain
    • Hospital Virgen de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endeavor Resolute Stent; Patients implanted with the Medtronic Endeavor Resolute stent	Device: Endeavor Resolute Stent; Single implantation; Other Names: Medtronic Endeavor Resolute Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall patient cost	During initial hospitalization and at 12 month follow-up
Number of major adverse cardiac events (MACE)	30 days, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible)	12 Months
Target Lesion Revascularization (TLR)	12 Months
Procedure, device and lesion success rate	30 Days

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: José Moreu Burgos, Dr., Hospital Virgen de la Salud

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 23, 2009
• First Posted (Estimate): February 24, 2009

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MDT-REDES1.7