Optical Coherence Tomography in Long Lesions (LONG OCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Case Western Reserve University
Medtronic Vascular
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT01133925
First received: May 28, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  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 assigned to receive multiple zotarolimus eluting stents (Resolute Sprint). The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up.Data will be compared to the historical arm of ODESSA trial (patients treated with multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents).


Condition Intervention Phase
Coronary Artery Disease
Device: Resolute Sprint
Device: Sirolimus Eluting Stent
Device: Paclitaxel Eluting Stent
Device: Zotarolimus 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: Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY

Resource links provided by NLM:


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

Primary Outcome Measures:
  • In stent NIH at overlapping vs non overlapping sites [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    In-stent neointimal hyperplasia (NIH) thickness at 6 months, as measured by OCT, at overlapping vs non overlapping sites: superiority of Endeavor Resolute stent compared to Endeavor Sprint

  • Percent uncovered and malapposed struts in OCT [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Proportion of stent struts uncovered and/or malapposed at 6 months, as measured by OCT, at overlapping vs non overlapping sites: non inferiority of Endeavor Resolute compared to Endeavor Sprint.


Secondary Outcome Measures:
  • Rate of > 30% uncovered struts/total number of struts per section. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MACE Rates [ Time Frame: 1-6 and 12 months ] [ Designated as safety issue: Yes ]
    All specific components of MACE (cardiac death, myocardial infarction (Q wave and non Q wave), and target vessel revascularization) will be summarized. MACE shall be assessed at, discharge (or within 7 days, whichever comes first), 1, 6 and 12 months post index procedure.

  • IVUS parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Based on IVUS Core Lab analysis including:

    • Neointimal volume, stent volume, lumen volume and percent net volume obstruction
    • Neointimal Thickness: Neointimal hyperplasia (NIH) inside all struts (mean, median, max)
    • Percent NIH Area= ([stent area-lumen area]/stent area) X 100
    • Rate of > 30% uncovered struts/total number of struts per section.

  • QCA Parameters [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Based on Angiographic Core Lab analysis utilizing Quantitative Coronary Angiography (QCA) including:

    Mean lumen diameter, acute gain, late loss through 6 months, and binary restenosis (≥ 50% diameter stenosis) rate at 6 months post index procedure.



Enrollment: 22
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ODESSA
ODESSA trial (NCT 00693030)Patients were randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. At 6-months follow-up coronary angiography (QCA), IVUS and Optical Coherence Tomography assessments were made. Data reported in J. Am. Coll. Cardiol. Intv. 2010;3;531-539. DOI 10.1016/j.jcin.2010.02.008.
Device: Sirolimus Eluting Stent
Cypher stents implanted in overlap
Device: Paclitaxel Eluting Stent
Taxus stents implanted in overlap
Device: Zotarolimus eluting stent
Endeavor stents implanted in overlap
Experimental: Resolute Sprint arm
Zotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions
Device: Resolute Sprint
Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap

Detailed Description:

It is not unknown whether overlapping drug-eluting stents provide increased vessel toxicity. 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 detects 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 assigned to receive multiple Resolute Sprint™. 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.

Obtained data will be compared with the data from a historical comparator (ODESSA trial that presented results from TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ stents implanted in overlap to treat long lesions.

  Eligibility

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

Inclusion Criteria:

  • Patient must be at least 18 years of age
  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
  • Native coronary artery disease with >75% diameter stenosis (no prior stent implant, no prior brachytherapy)
  • Lesion length > 20 mm
  • Vessel size between 2.5 and 3.5 mm
  • Multiple, overlapped Endeavor Resolute stents placement (intention to overlap > 4 mm).

Exclusion Criteria:

  • Left main coronary artery disease
  • Lesions in coronary artery bypass grafts
  • Acute myocardial infarction
  • Killip class IV
  • Recent major bleeding (6 months)
  • Renal failure with creatinine value > 2.5 mg/dl
  • Left ventricular global ejection fraction ≤ 30%.
  • Allergy to aspirin and or clopidogrel/ticlopidine
  • Patient in anticoagulant therapy
  • No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [> 3.5 mm in diameter])
  • Target lesion(s) located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy) < 9 months prior to index procedure
  • Target lesion restenotic from previous stent implantation
  • Any lesion (target or non-target) that has been previously treated with brachytherapy
  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: NCT01133925

Locations
Italy
Cardiovascular Department Ospedali Riuniti di Bergamo
Bergamo, BG, Italy, 24128
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Case Western Reserve University
Medtronic Vascular
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: NCT01133925     History of Changes
Other Study ID Numbers: BG-003-08
Study First Received: May 28, 2010
Last Updated: May 28, 2010
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Center for Clinical Trials-Ministry of Health

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
Coronary Artery Disease
Percutaneous Coronary Intervention
Drug Eluting Stent
Optical Coherence Tomography
Thrombosi
Long lesions in native vessels requiring overlap

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

ClinicalTrials.gov processed this record on August 28, 2014