Coronary Artery DiseaseRevElutionNCT02480348
Medtronic RevElution Trial
A study testing Polymer-free DES (Drug Eluting Stent) in people with Coronary Artery Disease, run by Medtronic Vascular at 15 sites in 3 countries.
Trial summary
The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter. 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?
- Polymer-free DES (Drug Eluting Stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 3 Dec 2015to 21 Oct 2019
- Phase
- Interventional
- 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
Who may be able to join
- Must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (CABG) surgery
- Must have evidence of ischemic heart disease
- Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent
- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Who cannot join
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Concurrent medical condition with a life expectancy of less than 5 years
- Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
- Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Australia13 sites
St. Andrew's Hospital
Adelaide, South Australia, 5000
Royal Adelaide Hospital
Adelaide, 5000
Wesley Hospital / HeartCare Partners
Auchenflower
Flinders Medical Center
Bedford Park, 5042
The Prince Charles Hospital
Chermside, Queensland, 4032
St. Vincent's Hospital
Darlinghurst, 2010
Royal Brisbane & Women's Hospital
Herston, 4029
Monash Medical Center
Melbourne, 3168
Northern Hospital
Melbourne
Fiona Stanley Hospital
Murdoch
John Hunter Hospital
New Lambton
Royal North Shore Hospital
St Leonards, 2065
Eastern Heart Clinic - Prince of Wales Hospital
Sydney, New South Wales, 2031
About this study
Official title: Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.
- Conditions
- Coronary Artery Disease
- Being tested
- Polymer-free DES (Drug Eluting 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.
Polymer-free DES (Drug Eluting Stent)Device
| Study group | Role | What they receive |
|---|---|---|
| Polymer-free DES (Drug Eluting Stent) | Experimental | Not described Receives: Device: Polymer-free DES (Drug Eluting Stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start3 Dec 2015
- Primary completion16 Jun 2017
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480348
- Sponsor's protocol ID
- Version 5.0, 29 JUL 2019
- Acronym
- RevElution
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
Publications
Worthley SG, Abizaid A, Kirtane AJ, Simon DI, Windecker S, Brar S, Meredith IT, Shetty S, Sinhal A, Almonacid AP, Chamie D, Maehara A, Stone GW; RevElution Investigators. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. JACC Cardiovasc Interv. 2017 Jan 23;10(2):147-156. doi: 10.1016/j.jcin.2016.10.020.
PubMed 28104208
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT02480348
- Acronym / sponsor ID
- RevElution / Version 5.0, 29 JUL 2019
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 24 Jun 2015 (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 purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polymer-free DES (Drug Eluting Stent) | Experimental | Device: Polymer-free DES (Drug Eluting Stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be an acceptable candidate for percutaneous coronary intervention, stenting, \& emergent coronary artery bypass graft (CABG) surgery
- Must have evidence of ischemic heart disease
- Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent
- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Key exclusion criteria (8 listed)
- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions
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 |
|---|---|---|
| Polymer-free DES (Drug Eluting Stent) | Device | Polymer-free DES (Drug Eluting Stent) |
Primary outcome
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
Time frame: 9 months
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 7 Jul 2020.
- Derived from this study: PubMed 28104208Worthley SG, Abizaid A, Kirtane AJ, Simon DI, Windecker S, Brar S, Meredith IT, Shetty S, Sinhal A, Almonacid AP, Chamie D, Maehara A, Stone GW; RevElution Investigators. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. JACC Cardiovasc Interv. 2017 Jan 23;10(2):147-156. doi: 10.1016/j.jcin.2016.10.020.
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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.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymer-free DES (Drug Eluting Stent) in people with Coronary Artery Disease, run by Medtronic Vascular at 15 sites in 3 countries.
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 8 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, Brazil, Singapore. 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?
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480348, which also lists 1 linked publication.
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 7 Jul 2020.