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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00850213
First received: February 23, 2009
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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 Intervention
Coronary Artery Disease
Device: Endeavor Resolute Stent

Study Type: Observational
Study Design: 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

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Overall patient cost [ Time Frame: During initial hospitalization and at 12 month follow-up ] [ Designated as safety issue: No ]
  • Number of major adverse cardiac events (MACE) [ Time Frame: 30 days, 6 months and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Procedure, device and lesion success rate [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Enrollment: 448
Study Start Date: February 2009
Study Completion Date: February 2011
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00850213     History of Changes
Other Study ID Numbers: MDT-REDES1.7
Study First Received: February 23, 2009
Last Updated: February 14, 2012
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014