Optical Coherence Tomography for Drug Eluting Stent Safety (ODESSA)

June 5, 2008 updated by: A.O. Ospedale Papa Giovanni XXIII

In-Vivo Vascular Response of Sirolimus-,Paclitaxel- and Zotarolimus-Eluting Stents in Long Lesions Requiring Overlapping. A Prospective, Randomized, Controlled Study Using Optical Coherence Tomography

Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detecs smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition.

Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis < 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.

OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of > 30% uncovered struts/total number of struts per section.

Study Type

Interventional

Enrollment (Anticipated)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24100
        • Recruiting
        • Cardiovascular Department Ospedali Riuniti di Bergamo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giulio Guagliumi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Native coronary artery disease with ≥ 75% diameter stenosis
  2. Lesion length ≥ 20 mm,
  3. Vessel size in between 2.5 and 3.5 mm.
  4. Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
  5. Signed patient informed consent

Exclusion Criteria:

  1. left main coronary artery disease,
  2. lesions in coronary artery bypass grafts,
  3. acute myocardial infarction,
  4. poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
  5. allergy to aspirin and or clopidogrel/ticlo,
  6. renal failure with creatinine value > 2.5,
  7. no suitable anatomy for OCT scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Device, Sirolimus drug-eluting stents implanted in overlap
Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)
comparison of multiple drug eluting stents
Other Names:
  • Cypher™ (Cordis Corp, Johnson & Johnson Co) DES
Active Comparator: 2
Device, paclitaxel polymer drug eluting stent
Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)
comparison of multiple drug eluting coronary stents
Other Names:
  • Taxus Libertè™ (Boston Scientific, Natick MS) DES
Active Comparator: 3
Device, zotarolimus drug eluting stent
Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)
comparison of multiple drug eluting coronary stents
Other Names:
  • Endeavor™ (Medtronic, Santa Rosa, CA) DES
Active Comparator: 4
bare metal coronary stents
Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)
comparison of DES in overlap vs BMS in overlap
Other Names:
  • Libertè™ BMS(Boston Scientific, Natick, MS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of uncovered and/or malapposed stent struts at overlapping versus non overlapping sites in drug eluting vs bare metal stents
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ischemia Driven Target Vessel Failure
Time Frame: 12 months
12 months
Number of uncovered and/or malapposed stent struts at overlapping sites in sirolimus-, paclitaxel- or zotarolimus eluting stents
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborators

Boston Scientific Corporation
Medtronic Vascular
Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Anticipated)

June 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2008

Last Update Submitted That Met QC Criteria

June 5, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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