Coronary Artery DiseaseRI-USNCT01638507
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
A study testing Resolute Integrity Stent in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.
Trial summary
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System. 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?
- Resolute Integrity Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2015
- Phase
- Interventional
- 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
General and Angiographic Inclusion Criteria highlights:
- Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- Informed consent
- Patient agrees to comply with specified follow-up evaluations
- Single target lesion or two target lesions located in separate coronary arteries
- De novo lesion(s) in native coronary artery(ies)
- Target lesion(s) ≤ 27 mm in length
- Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm
General and Angiographic Exclusion Criteria highlights:
- Within 7 days of index procedure platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White Blood Cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
- Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (CK-MB) > lab upper limit of normal)
- Previous PCI of target vessel(s) within 9 months prior to the procedure
- Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- History of stroke or Transient Ischemic Attack (TIA) within prior 6 months
- Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- Inability to comply with required trial antiplatelet regimen
- Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
- Unprotected left main coronary artery disease
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital Health Center
Syracuse, New York, 13203
About this study
Official title: Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
Read the detailed description
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
- Conditions
- Coronary Artery Disease
- Being tested
- Resolute Integrity Stent
- Keywords
- TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), Coronary Artery Disease, MYOCARDIAL INFARCTION (MI), PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT THROMBOSIS, TARGET LESION FAILURE (TLF)
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute Integrity StentDevice
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
| Study group | Role | What they receive |
|---|---|---|
| Resolute Integrity | Other | Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent) Receives: Device: Resolute Integrity Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
Measured: 12 months
Secondary outcomes (9)
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
Measured: 12 months
Clinical Endpoint: Death
Measured: 12 months
Dual Antiplatelet Therapy (DAPT) Compliance
Measured: 12 months
Clinical Endpoint: TLR
Measured: 12 months
Clinical Endpoint: TVR
Measured: 12 months
Clinical Endpoint: MI
Measured: 12 months
Clinical Endpoint: ST
Measured: 12 months
Clinical Endpoint: Stroke
Measured: 12 months
Clinical Endpoint: Bleeding Complications in General
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2014
- Study completionJun 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Caputo, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638507
- Sponsor's protocol ID
- IP 126
- Acronym
- RI-US
- Status last verified
- Mar 2019
- First submitted
- 9 Jul 2012
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2 mm
- ClinicalTrials.gov ID
- NCT01638507
- Acronym / sponsor ID
- RI-US / IP 126
- Conditions
- Coronary Artery Disease
- Keywords
- TARGET LESION REVASCULARIZATION (TLR), TARGET VESSEL REVASCULARIZATION (TVR), Coronary Artery Disease, MYOCARDIAL INFARCTION (MI), PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT THROMBOSIS, TARGET LESION FAILURE (TLF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Posted 25 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
Detailed description
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resolute Integrity | Other | Device: Resolute Integrity StentMedtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Resolute Integrity StentMedtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Device | Resolute Integrity |
Primary outcome
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
Time frame: 12 months
9 secondary outcomes
Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI
Time frame: 12 months
Clinical Endpoint: Death
Time frame: 12 months
Dual Antiplatelet Therapy (DAPT) Compliance
Time frame: 12 months
Clinical Endpoint: TLR
Time frame: 12 months
Clinical Endpoint: TVR
Time frame: 12 months
Clinical Endpoint: MI
Time frame: 12 months
Clinical Endpoint: ST
Time frame: 12 months
Clinical Endpoint: Stroke
Time frame: 12 months
Clinical Endpoint: Bleeding Complications in General
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- 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.
Ronald Caputo, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Integrity Stent in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 3 Apr 2019. 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 United States. 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 25 Nov 2015). 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?
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) (time frame: 12 months). 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 3 Apr 2019.