NCT00850213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 23, 2017

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

February 23, 2009

Last Update Submit

March 22, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Endeavor Resolute Stent

Patients implanted with the Medtronic Endeavor Resolute stent

Device: Endeavor Resolute Stent

Interventions

Endeavor Resolute StentDEVICE

Single implantation

Also known as: Medtronic Endeavor Resolute Coronary Stent System
Endeavor Resolute Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Juan Canalejo

A Coruña, Spain

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital de León

León, Spain

Location

Hospital Cínico Universitario de Málaga

Málaga, Spain

Location

Hospital Virgen de la Salud

Toledo, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • José Moreu Burgos, Dr.

    Hospital Virgen de la Salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2009

First Posted

February 24, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 23, 2017

Record last verified: 2012-02

Locations

ES(6)