Clinical trial NCT01133925: Optical Coherence Tomography in Long Lesions
Official title: Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Percutaneous Coronary Intervention
Drug Eluting Stent
Optical Coherence Tomography
Thrombosi
Long lesions in native vessels requiring overlap
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Medtronic Vascular
First posted: 2010-05-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: In stent NIH at overlapping vs non overlapping sites
timeFrame: 6 month
measure: Percent uncovered and malapposed struts in OCT
timeFrame: 6 month
Secondary outcomes:
measure: Rate of > 30% uncovered struts/total number of struts per section.
timeFrame: 6 months
measure: MACE Rates
timeFrame: 1-6 and 12 months
measure: IVUS parameters
timeFrame: 6 months
measure: QCA Parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Cardiovascular Department Ospedali Riuniti di Bergamo
state: BG
Study officials:
affiliation: Cardiovascular Department Ospedali Riuniti di Bergamo
name: Giulio Guagliumi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA; ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.
citation: Guagliumi G, Ikejima H, Sirbu V, Bezerra H, Musumeci G, Lortkipanidze N, Fiocca L, Tahara S, Vassileva A, Matiashvili A, Valsecchi O, Costa M. Impact of drug release kinetics on vascular response to different zotarolimus-eluting stents implanted in patients with long coronary stenoses: the LongOCT study (Optical Coherence Tomography in Long Lesions). JACC Cardiovasc Interv. 2011 Jul;4(7):778-85. doi: 10.1016/j.jcin.2011.04.007.