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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Ospedale della Misericordia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ospedale della Misericordia
ClinicalTrials.gov Identifier:
NCT00870038
First received: March 25, 2009
Last updated: July 21, 2010
Last verified: March 2009
  Purpose

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).


Condition Intervention Phase
Angioplasty, Transluminal, Percutaneous Coronary
Percutaneous Coronary Intervention
Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent
Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Re-Endothelialization Might Not be the Unique Solution to Prevent Restenosis. The EREMUS Study

Resource links provided by NLM:


Further study details as provided by Ospedale della Misericordia:

Primary Outcome Measures:
  • Late luminal loss between the three groups at 6 months angiographic follow up. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angiographic restenosis (6 months angiographic follow up). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: December 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Paclitaxel eluting balloon (Elutax) + Genous stent
Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent
Other Names:
  • Elutax balloon, Aachen Resonance GmbH, Bavaria, Germany;
  • Genous stent, Orbus Neich, Fort Lauderdale, FL.
Experimental: 2
Uncoated balloon + Genous stent
Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent
Predilatation with uncoated balloon, the stenting with Genous stent.
Other Name: Genous stent, Orbus Neich, Fort Lauderdale, FL.
Active Comparator: 3
Drug eluting stent (Taxus stent)
Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Predilatation with uncoated balloon, the placement of a Taxus stent.
Other Name: Taxus stent, Boston Scientific, Natick, MA.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870038

Contacts
Contact: Bernardo Cortese, MD +39 02 55033507 bcortese@gmail.com
Contact: Ugo Limbruno, MD, PhD bcortese@gmail.com

Locations
Italy
U.O. Emodinamica, Ospedale della Misericordia Not yet recruiting
Grosseto, Italy, 58100
Principal Investigator: Bernardo Cortese, MD         
Sponsors and Collaborators
Ospedale della Misericordia
Investigators
Principal Investigator: Bernardo Cortese, MD, FESC Ospedale Maggiore Policlinico, Milano, Italy
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernardo Cortese, Ospedale della Misericordia
ClinicalTrials.gov Identifier: NCT00870038     History of Changes
Other Study ID Numbers: Bernard1
Study First Received: March 25, 2009
Last Updated: July 21, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale della Misericordia:
PCI
stent
drug eluting stent
reendothelialization
restenosis
Percutaneous Coronary Angioplasty

Additional relevant MeSH terms:
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014