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Coronary Artery DiseasePhase 1/2NCT00248079

The Medtronic RESOLUTE Clinical Trial

A Phase 1/2 study testing Coronary Artery Stenting in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 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?
Coronary Artery Stenting
Type of treatment
Medical device
How many people
139 participants
Where
1 siteAustralia
Study dates
Nov 2005to Oct 2011
Phase
Phase 1/2
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

  • Patient is at least 18 years old
  • Patient is an acceptable candidate for percutaneous coronary intervention and emergent coronary artery bypass graft surgery
  • Patient has clinical evidence of ischemic heart disease or a positive functional study
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
  • Patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee of the respective investigational site
  • Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed. Patients participating in the PK sub-study must agree to the additional follow-up procedures as required by the sub-study

Who cannot join

  • Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coating components or a sensitivity to contrast media, which cannot be adequately pre-medicated
  • History of an allergic reaction or significant sensitivity to drugs such as ABT-578, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
  • Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³
  • Serum creatinine level > 170 micromol/L within 7 days prior to index procedure
  • Evidence of an acute myocardial infarction within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction or non-Q wave myocardial infarction having CK enzymes > 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal))
  • Previous stenting anywhere in the target vessel
Show all 20Show fewer
  • PCI of the target vessel within 30 days prior to the procedure
  • Implantation of a drug eluting stent in any non-target vessel within 30 days prior to the procedure. Implantation of a Cypher stent in any non-target vessel within 90 days prior to the procedure
  • PCI of a non-target vessel with a bare metal stent within 30 days prior to the procedure that results in any MACE event. If the bare metal stent is implanted within 72 hours prior to the procedure, a post procedural serial CK or CK-MB measurement above the investigational site's upper limit of normal (two below upper normal required for enrollment)
  • PCI of a non-target vessel within 24 hours prior to the procedure
  • Planned PCI of any vessel within 30 days post-procedure. Planned stenting of any vessel with a Cypher or Endeavor stent within 60 days post-procedure
  • Planned PCI of the target vessel within 9 months post-procedure
  • During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement
  • History of a stroke or transient ischemic attack within the prior 6 months
  • Active peptic ulcer or upper gastrointestinal 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 12 months
  • Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy
  • Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
  • Documented left ventricular ejection fraction < 30% at the most recent evaluation

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Monash Medical Centre

    Melbourne

Other trials in Australia

About this study

Official title: The Clinical Response Evaluation of the Medtronic Endeavor CR ABT-578 Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

To evaluate the clinical safety, efficacy, and pharmacokinetics (PK) of the Endeavor Resolute Zotorolimus Eluting Coronary Stent System for the treatment of single de novo lesions in native coronary arteries with a reference vessel diameter (RVD) between 2.5 and 3.5 mm in diameter.

Being tested
Coronary Artery Stenting
Keywords
Coronary Disease
Medical subject headings
Coronary Artery Disease, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Artery StentingDevice

    Initial implant of drug eluting stent (zotarolimus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late lumen loss (in-stent) as measured by quantitative coronary angiography (QCA)

    Measured: 9 months

Secondary outcomes (7)

  1. Major adverse cardiac event (MACE) rate

    Measured: 30 days, 4, 6, 9 & 12 months

  2. Acute success (device, lesion, and procedure)

    Measured: 4 or 9 Months

  3. Target vessel failure (TVF)

    Measured: 9 months

  4. Target lesion revascularization (TLR)

    Measured: 9 months

  5. Neointimal hyperplastic volume and percent volume obstruction (%VO) as measured by intravascular ultrasound (IVUS)

    Measured: 4 or 9 months

  6. Pharmacokinetic parameters

    Measured: last measurement at 60 days

  7. Angiographic parameters (in-stent and in-segment)

    Measured: 4 or 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2007
  4. Study completionOct 2011

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00248079
Sponsor's protocol ID
IP069
Status last verified
Oct 2011
First submitted
1 Nov 2005
Last updated
20 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.

    PubMed 23523454

  • Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.

    PubMed 23468513

  • Waseda K, Ako J, Yamasaki M, Koizumi T, Sakurai R, Hongo Y, Koo BK, Ormiston J, Worthley SG, Whitbourn RJ, Walters DL, Meredith IT, Fitzgerald PJ, Honda Y. Impact of polymer formulations on neointimal proliferation after zotarolimus-eluting stent with different polymers: insights from the RESOLUTE trial. Circ Cardiovasc Interv. 2011 Jun;4(3):248-55. doi: 10.1161/CIRCINTERVENTIONS.110.957548. Epub 2011 May 17.

    PubMed 21586691

  • Waseda K, Ako J, Yamasaki M, Koizumi T, Ormiston J, Worthley SG, Whitbourn RJ, Walters DL, Honda Y, Meredith IT, Fitzgerald PJ; RESOLUTE Trial Investigators. Short- and mid-term intravascular ultrasound analysis of the new zotarolimus-eluting stent with durable polymer - results from the RESOLUTE trial -. Circ J. 2010 Oct;74(10):2097-102. doi: 10.1253/circj.cj-10-0063. Epub 2010 Aug 3.

    PubMed 20689221

  • Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138.

    PubMed 20142198

  • Meredith IT, Worthley S, Whitbourn R, Walters DL, McClean D, Horrigan M, Popma JJ, Cutlip DE, DePaoli A, Negoita M, Fitzgerald PJ; RESOLUTE Investigators. Clinical and angiographic results with the next-generation resolute stent system: a prospective, multicenter, first-in-human trial. JACC Cardiovasc Interv. 2009 Oct;2(10):977-85. doi: 10.1016/j.jcin.2009.07.007.

    PubMed 19850258

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Coronary Artery Stenting in people with Coronary Artery Disease, run by Medtronic Vascular at 1 site in Australia.

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 6 inclusion and 20 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 20 Oct 2011. 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 Australia. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 (in-stent) as measured by quantitative coronary angiography (QCA) (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 NCT00248079, which also lists 6 linked publications.

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 20 Oct 2011.

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