AzTrials
AzTrials

Angioplasty, Transluminal, Percutaneous CoronaryPhase 4EREMUSNCT00870038

To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study

A Phase 4 study testing Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent, Percutaneous coronary intervention: Uncoated balloon + Genous stent and Percutaneous coronary intervention: Drug eluting stent (Taxus stent) in people with Angioplasty, Transluminal, Percutaneous Coronary and Percutaneous Coronary Intervention, run by Ospedale della Misericordia at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel). Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent, Percutaneous coronary intervention: Uncoated balloon + Genous stent and Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteItaly
Study dates
Dec 2010to Jan 2012
Phase
Phase 4
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable or unstable angina pectoris suitable to PCI of at least one coronary vessel
  • Age >18 years

Who cannot join

  • Recent (<72 hours) acute myocardial infarction
  • Creatinine clearance <40 ml/min
  • Allergy or hypersensitivity to at least two between: aspirin, clopidogrel, heparin, bivalirudin, paclitaxel, contrast media
  • Life expectancy <1 year

Trial locations and contacts

1 site in 1 country.

Bernardo Cortese, MD contact

+39 02 55033507

bcortese@gmail.com

Ugo Limbruno, MD, PhD contact

bcortese@gmail.com

Italy1 site

  • U.O. Emodinamica, Ospedale della Misericordia

    Grosseto, 58100

    Bernardo Cortese, MD

Other trials in Italy

About this study

Official title: Early Re-Endothelialization Might Not be the Unique Solution to Prevent Restenosis. The EREMUS Study

The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel).

Being tested
Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent, Percutaneous coronary intervention: Uncoated balloon + Genous stent, Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Keywords
PCI, stent, drug eluting stent, reendothelialization, restenosis, Percutaneous Coronary Angioplasty

What participants receive

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

  • Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stentDevice

    Also called Elutax balloon, Aachen Resonance GmbH, Bavaria, Germany;, Genous stent, Orbus Neich, Fort Lauderdale, FL.

    Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent

  • Percutaneous coronary intervention: Uncoated balloon + Genous stentDevice

    Also called Genous stent, Orbus Neich, Fort Lauderdale, FL.

    Predilatation with uncoated balloon, the stenting with Genous stent.

  • Percutaneous coronary intervention: Drug eluting stent (Taxus stent)Device

    Also called Taxus stent, Boston Scientific, Natick, MA.

    Predilatation with uncoated balloon, the placement of a Taxus stent.

Study groups in NCT00870038
Study groupRoleWhat they receive
1ExperimentalPaclitaxel eluting balloon (Elutax) + Genous stent
Receives: Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
2ExperimentalUncoated balloon + Genous stent
Receives: Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent
3Active comparatorDrug eluting stent (Taxus stent)
Receives: Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)

What is being measured

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

  1. Late luminal loss between the three groups at 6 months angiographic follow up.

    Measured: 6 months

  2. Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.

    Measured: 6 months

Secondary outcomes (2)

  1. Angiographic restenosis (6 months angiographic follow up).

    Measured: 6 months

  2. Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).

    Measured: 6 months

Timeline

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

  1. First posted26 Mar 2009 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2011 (estimated)
  4. Study completionJan 2012 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00870038
Sponsor's protocol ID
Bernard1
Acronym
EREMUS
Status last verified
Mar 2009
First submitted
25 Mar 2009
Last updated
22 Jul 2010
Results posted
No
Data monitoring committee
No

Publications

  • Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, Lopez-Minguez JR, Angel J, Auge JM, Gomez-Recio M, Moris C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. doi: 10.1016/s0735-1097(03)00852-0.

    PubMed 12957423

  • Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.

    PubMed 17869634

  • Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.

    PubMed 15893169

  • Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26.

    PubMed 18082503

  • Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW; Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007 Mar 17;369(9565):907-19. doi: 10.1016/S0140-6736(07)60450-4.

    PubMed 17368152

  • Cortese B, Danzi GB, Piti A, Severi S, Limbruno U. Rationale and design of the randomized, multicenter EREMUS trial, a study that investigates how to achieve low restenosis and early reendothelialization after percutaneous coronary interventions. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):32-7. doi: 10.1002/ccd.22856. Epub 2011 Mar 16.

    PubMed 21413116

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent, Percutaneous coronary intervention: Uncoated balloon + Genous stent and Percutaneous coronary intervention: Drug eluting stent (Taxus stent) in people with Angioplasty, Transluminal, Percutaneous Coronary and Percutaneous Coronary Intervention, run by Ospedale della Misericordia at 1 site in Italy.

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 2 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: status not confirmed, as of the sponsor's last update on 22 Jul 2010. 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 Italy. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bernardo Cortese, MD (+39 02 55033507, bcortese@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late luminal loss between the three groups at 6 months angiographic follow up. (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT00870038, 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 22 Jul 2010.

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