Coronary Artery DiseaseREDESNCT00850213
Assessment of Clinical Performance and Costs of the Endeavor Resolute Stent "in Real Life" in Spain.
An observational study of Coronary Artery Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Endeavor Resolute Stent
- Type of treatment
- Medical device
- How many people
- 448 participants
- Where
- 6 sitesSpain
- Study dates
- Feb 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Juan Canalejo
A Coruña
Hospital General de Alicante
Alicante
Hospital Universitari de Bellvitge
Barcelona
Hospital de León
León
Hospital Cínico Universitario de Málaga
Málaga
Hospital Virgen de la Salud
Toledo
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Endeavor Resolute Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor Resolute StentDevice
Also called Medtronic Endeavor Resolute Coronary Stent System
Single implantation
| Study group | Role | What they receive |
|---|---|---|
| Endeavor Resolute Stent | Patients implanted with the Medtronic Endeavor Resolute stent Receives: Device: Endeavor Resolute Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient cost
Measured: During initial hospitalization and at 12 month follow-up
Number of major adverse cardiac events (MACE)
Measured: 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)
Measured: 12 Months
Target Lesion Revascularization (TLR)
Measured: 12 Months
Procedure, device and lesion success rate
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Moreu Burgos, Dr., Principal investigator, Hospital Virgen de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850213
- Sponsor's protocol ID
- MDT-REDES1.7
- Acronym
- REDES
- Status last verified
- Feb 2012
- First submitted
- 23 Feb 2009
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Redes - Evaluación Del Comportamiento clínico y Del Coste Del Stent Coronario Endeavor Resolute de Medtronic "en el Mundo Real" en España
- ClinicalTrials.gov ID
- NCT00850213
- Acronym / sponsor ID
- REDES / MDT-REDES1.7
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endeavor Resolute Stent | – | Device: Endeavor Resolute StentPatients implanted with the Medtronic Endeavor Resolute stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endeavor Resolute StentAlso: Medtronic Endeavor Resolute Coronary Stent SystemSingle implantation | Device | Endeavor Resolute Stent |
Primary outcome
Overall patient cost
Time frame: 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
3 secondary outcomes
Rate of stent thrombosis (according to ARC criteria, defined as definite/confirmed, probable and possible)
Time frame: 12 Months
Target Lesion Revascularization (TLR)
Time frame: 12 Months
Procedure, device and lesion success rate
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Moreu Burgos, Dr. principal investigator
Hospital Virgen de la Salud
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall patient cost (time frame: During initial hospitalization and at 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.