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

March 22, 2017 updated by: Medtronic Bakken Research Center

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

448

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: During initial hospitalization and at 12 month follow-up
During initial hospitalization and at 12 month follow-up
Number of major adverse cardiac events (MACE)
Time Frame: 30 days, 6 months and 1 year
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)
Time Frame: 12 Months
12 Months
Target Lesion Revascularization (TLR)
Time Frame: 12 Months
12 Months
Procedure, device and lesion success rate
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Investigators

  • Principal Investigator: José Moreu Burgos, Dr., Hospital Virgen De La Salud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • MDT-REDES1.7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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