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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| Medtronic Vascular | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODESSA | Active Comparator | 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. |
|
| Resolute Sprint arm | Experimental | Zotarolimus Eluting stents (Resolute Sprint) implanted in overlap to treat long coronary lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Sprint | Device | Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap |
|
| Measure | Description | Time Frame |
|---|---|---|
| In stent NIH at overlapping vs non overlapping sites | 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 | 6 month |
| Percent uncovered and malapposed struts in OCT | 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. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of > 30% uncovered struts/total number of struts per section. | 6 months | |
| MACE Rates | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giulio Guagliumi, MD | Cardiovascular Department Ospedali Riuniti di Bergamo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Department Ospedali Riuniti di Bergamo | Bergamo | BG | 24128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20488410 | Background | 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. | |
| 21777886 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 29, 2020 | |
| Reset | May 14, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2020 | May 14, 2020 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Sirolimus Eluting Stent | Device | Cypher stents implanted in overlap |
|
| Paclitaxel Eluting Stent | Device | Taxus stents implanted in overlap |
|
| Zotarolimus eluting stent | Device | Endeavor stents implanted in overlap |
|
| 1-6 and 12 months |
| IVUS parameters | Based on IVUS Core Lab analysis including:
| 6 months |
| QCA Parameters | 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. | 6 months |
| Derived |
| 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |