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Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease (OCTAXUS)

This study has been completed.
Sponsor:
Collaborators:
Case Western Reserve University
Boston Scientific Corporation
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00704145
First received: June 20, 2008
Last updated: February 5, 2010
Last verified: February 2010
  Purpose

A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions


Condition Intervention Phase
Coronary Artery Disease
Device: Taxus Libertè™ paclitaxel drug-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Optical Coherence Tomography Study on Completeness of Strut Coverage and Vessel Wall Response at 3-6 and 9 Months Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT [ Time Frame: 3-6-9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • % Incomplete apposition at different point of FU (3-6-9 months) [ Time Frame: 3-6-9 months ] [ Designated as safety issue: Yes ]
  • Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months) [ Time Frame: 3-6-9 months ] [ Designated as safety issue: Yes ]
  • OCT Neointima thickness overtime [ Time Frame: 3-6-9 months ] [ Designated as safety issue: No ]
  • Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Adjudicated MACE rate at 30 days and 12 months [ Time Frame: 30 days and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2007
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Device, paclitaxel drug-eluting stent
Device: Taxus Libertè™ paclitaxel drug-eluting stent
device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant
Other Name: Taxus Libertè™ (Boston Scientific,Natick,MS)

Detailed Description:

Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following paclitaxel-eluting stent implantation, in patients with multivessel disease treated with staged PCI procedures. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time point. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and 9 months elective follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents
  2. Native coronary artery disease with >= 75% diameter stenosis
  3. Vessel size in between 2.5 and 3.5 mm.
  4. Written informed consent signed

Exclusion Criteria:

  1. No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).
  2. significant left main coronary artery disease,
  3. lesions in bypass grafts,
  4. acute myocardial infarction,
  5. poor cardiac function as defined by left ventricular ejection fraction ≤ 30%.
  6. allergy to aspirin and or clopidogrel/ticlopidine,
  7. Renal failure with creatinine value > 2.5 mg/dl
  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: NCT00704145

Locations
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Case Western Reserve University
Boston Scientific Corporation
Investigators
Principal Investigator: Giulio Guagliumi, MD Cardiovascular Department Ospedali Riuniti di Bergamo
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giulio Guagliumi, Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier: NCT00704145     History of Changes
Other Study ID Numbers: 1087/2007
Study First Received: June 20, 2008
Last Updated: February 5, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
Drug Eluting Stents
Percutaneous Coronary Interventions
Optical Coherence Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
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