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OpenTrials
Completed

NCT Number: NCT00850213

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Juan Canalejo, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endeavor Resolute stent

Device

Single implantation

Other names: Medtronic Endeavor Resolute Coronary Stent System

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Acronym: REDES

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 24, 2009
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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