Optical Coherence Tomography in Long Lesions (LONG OCT)
|ClinicalTrials.gov Identifier: NCT01133925|
Recruitment Status : Unknown
Verified May 2010 by A.O. Ospedale Papa Giovanni XXIII.
Recruitment status was: Active, not recruiting
First Posted : May 31, 2010
Last Update Posted : May 31, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Resolute Sprint Device: Sirolimus Eluting Stent Device: Paclitaxel Eluting Stent Device: Zotarolimus eluting stent||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optical Coherence Tomography in Long Native Coronary Artery Lesions Treated With Multiple Novel Zotarolimus-eluting Stents: LONG OCT STUDY|
|Study Start Date :||May 2008|
|Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||May 2011|
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 overlapDevice: Paclitaxel Eluting Stent
Taxus stents implanted in overlapDevice: 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
- In stent NIH at overlapping vs non overlapping sites [ Time Frame: 6 month ]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 ]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.
- Rate of > 30% uncovered struts/total number of struts per section. [ Time Frame: 6 months ]
- MACE Rates [ Time Frame: 1-6 and 12 months ]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 ]
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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133925
|Cardiovascular Department Ospedali Riuniti di Bergamo|
|Bergamo, BG, Italy, 24128|
|Principal Investigator:||Giulio Guagliumi, MD||Cardiovascular Department Ospedali Riuniti di Bergamo|