Coronary Artery DiseaseDELIVERNCT01297257
DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
An observational study of Coronary Artery Disease, run by Medtronic Vascular at 1 site in Netherlands.
Trial summary
The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients. 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?
- Stent implantation
- Type of treatment
- Medical device
- How many people
- 7,845 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2011to Apr 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The study population will consist of patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft that are amenable to percutaneous treatment.
Who may be able to join
- Minimum legal age (18)
- Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
- Patient has consented to participate and authorized in writing the collection and release of medical information
Who cannot join
- Pregnancy
- Participating in another study that interferes with study endpoints
- Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media
- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.
- Conditions
- Coronary Artery Disease
- Being tested
- Stent implantation
- 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.
Stent implantationDevice
Single arm, open label stent implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery Success
The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.
Measured: stent implantation until hospital discharge (average 1-3 days)
Secondary outcomes (1)
In-hospital MACE (Major Adverse Cardiac Event)
Measured: stent implantation until hospital discharge (average 1-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297257
- Sponsor's protocol ID
- IP992
- Acronym
- DELIVER
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2010
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
- ClinicalTrials.gov ID
- NCT01297257
- Acronym / sponsor ID
- DELIVER / IP992
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,845 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft that are amenable to percutaneous treatment.
Key inclusion criteria (3 listed)
- Minimum legal age (18)
- Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
- Patient has consented to participate and authorized in writing the collection and release of medical information
Key exclusion criteria (4 listed)
- Pregnancy
- Participating in another study that interferes with study endpoints
- Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media
- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated
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 |
|---|---|---|
| Stent implantationSingle arm, open label stent implantation | Device | – |
Primary outcome
Delivery Success
Time frame: stent implantation until hospital discharge (average 1-3 days)
The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.
1 secondary outcome
In-hospital MACE (Major Adverse Cardiac Event)
Time frame: stent implantation until hospital discharge (average 1-3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Vascular at 1 site in Netherlands.
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 3 inclusion and 4 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Delivery Success (time frame: stent implantation until hospital discharge (average 1-3 days)). 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 6 Mar 2014.