NCT00870038

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 22, 2010

Status Verified

March 1, 2009

Enrollment Period

8 months

First QC Date

March 25, 2009

Last Update Submit

July 21, 2010

Conditions

Angioplasty, Transluminal, Percutaneous CoronaryPercutaneous Coronary Intervention

Keywords

PCIstentdrug eluting stentreendothelializationrestenosisPercutaneous Coronary Angioplasty

Outcome Measures

Primary Outcomes (2)

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

    6 months

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

    6 months

Secondary Outcomes (2)

  • Angiographic restenosis (6 months angiographic follow up).

    6 months

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

    6 months

Study Arms (3)

1

EXPERIMENTAL

Paclitaxel eluting balloon (Elutax) + Genous stent

Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent

2

EXPERIMENTAL

Uncoated balloon + Genous stent

Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent

3

ACTIVE COMPARATOR

Drug eluting stent (Taxus stent)

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

Interventions

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

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

Also known as: Elutax balloon, Aachen Resonance GmbH, Bavaria, Germany;, Genous stent, Orbus Neich, Fort Lauderdale, FL.
1
Percutaneous coronary intervention: Uncoated balloon + Genous stentDEVICE

Predilatation with uncoated balloon, the stenting with Genous stent.

Also known as: Genous stent, Orbus Neich, Fort Lauderdale, FL.
2
Percutaneous coronary intervention: Drug eluting stent (Taxus stent)DEVICE

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

Also known as: Taxus stent, Boston Scientific, Natick, MA.
3

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Emodinamica, Ospedale della Misericordia

Grosseto, 58100, Italy

Location

Related Publications (6)

  • 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.

    PMID: 12957423RESULT

  • 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.

    PMID: 17869634RESULT

  • 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.

    PMID: 15893169RESULT

  • 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.

    PMID: 18082503RESULT

  • 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.

    PMID: 17368152RESULT

  • 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.

    PMID: 21413116DERIVED

Study Officials

  • Bernardo Cortese, MD, FESC

    Ospedale Maggiore Policlinico, Milano, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernardo Cortese, MD

CONTACT

+39 02 55033507bcortese@gmail.com

Ugo Limbruno, MD, PhD

CONTACT

bcortese@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

December 1, 2010

Primary Completion

August 1, 2011

Study Completion

January 1, 2012

Last Updated

July 22, 2010

Record last verified: 2009-03

Locations

IT(1)