Optical Coherence Tomography for Drug Eluting Stent Safety (ODESSA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Case Western Reserve University
Medtronic Vascular
Boston Scientific Corporation
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00693030
First received: June 4, 2008
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Device: sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)
Device: paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)
Device: zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)
Device: Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemia Driven Target Vessel Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of uncovered and/or malapposed stent struts at overlapping sites in sirolimus-, paclitaxel- or zotarolimus eluting stents [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 77
Study Start Date: August 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Libertè™ BMS(Boston Scientific, Natick, MS)

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.

  Eligibility

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

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
  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: NCT00693030

Contacts
Contact: Monia Lorini, MD 39-03-526-9751 mlorini@ospedaliriuniti.bergamo.it

Locations
Italy
Cardiovascular Department Ospedali Riuniti di Bergamo Recruiting
Bergamo, Italy, 24100
Contact: Giulio Guagliumi, MD    39-03-526-6455    guagliumig@interfree.it   
Contact: Giuseppe Musumeci, MD    39-03-526-6455    giuseppe.musumeci@gmail.it   
Principal Investigator: Giulio Guagliumi, MD         
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Case Western Reserve University
Medtronic Vascular
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, Cardiovascular Department Ospedali Riuniti di Bergamo ITALY
ClinicalTrials.gov Identifier: NCT00693030     History of Changes
Other Study ID Numbers: 0106
Study First Received: June 4, 2008
Last Updated: June 5, 2008
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
Coronary Artery Disease
Percutaneous Coronary Interventions
Drug-Eluting stents
Optical Coherence Tomography
Thrombosis
Long lesions in native vessel requiring stents in overlap

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Sirolimus
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014