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

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ClinicalTrials.gov Identifier: NCT00850213
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Endeavor Resolute Stent

Study Design

Study Type : Observational
Actual Enrollment : 448 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : February 2009
Primary Completion Date : February 2011
Study Completion Date : February 2011
Groups and Cohorts

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


Outcome Measures

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

Secondary Outcome Measures :
  1. Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible) [ Time Frame: 12 Months ]
  2. Target Lesion Revascularization (TLR) [ Time Frame: 12 Months ]
  3. Procedure, device and lesion success rate [ Time Frame: 30 Days ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850213


Locations
Spain
Hospital Juan Canalejo
A Coruna, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital de León
Leon, Spain
Hospital Cínico Universitario de Málaga
Malaga, Spain
Hospital Virgen de la Salud
Toledo, Spain
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: José Moreu Burgos, Dr. Hospital Virgen de la Salud
More Information

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00850213     History of Changes
Other Study ID Numbers: MDT-REDES1.7
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: February 2012

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases