Resolute ZES (zotarolimus-eluting stent) / Medtronic 
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  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial primary completion date:  ONYX PAS: RESOLUTE ONYX Post-Approval Study (clinicaltrials.gov) -  Oct 3, 2019   
    P=N/A,  N=510, Recruiting, 
    Trial primary completion date: Nov 2019 --> Oct 2018
  • ||||||||||  paclitaxel / Generic Mfg.
    Drug-Coated Balloon Versus Drug-Eluting Stent for the Treatment of Small-Vessel Disease: 2-Year Clinical Outcomes of the RESTORE SVD China Randomized Trial () -  Oct 1, 2019 - Abstract #TCT2019TCT_536;    
    The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%; p = 0.72). A total of 254 (97.3%) patients have completed 2-year follow-up.Small-Vessel Restore DCB Group (Patients, n = 116; Lesions, n = 116)Small-Vessel Resolute DES Group (Patients, n = 114; Lesions, n = 114)p ValueVery Small-Vessel Group (Patients, n = 32; Lesions, n = 32)Age60.1 ± 10.560.5 ± 10.80.7858.0 ± 9.9Male66.4% (77)77.2% (88)0.0775.0% (24)Diabetes mellitus39.7% (46)42.1% (48)0.7140.6% (13)Reference vessel diameter, mm2.11 ± 0.272.21 ± 0.290.011.86 ± 0.28Lesion length, mm10.5 ± 4.810.8 ± 5.20.6312.2 ± 5.6Post-procedure in-segment diameter stenosis, %19.8 ± 8.812.6 ± 6.4< 0.00123.7 ± 10.19-month in-segment diameter stenosis, % (per lesion)29.3 ± 20.223.9 ± 15.90.0438.4 ± 21.51-year target lesion failure4.4% (5)2.6% (3)0.726.3% (2)1-year def/prob device thrombosis0% (0)0% (0)—0% (0) Conclusion The 2-year clinical follow-up results and other relevant analyses will be presented for the first time at the TCT 2019.
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Efficacy and Safety of the Newer Generation Zotarolimus-Eluting Stent in Routine Clinical Practice: Data From the IRIS-DES Registry () -  Oct 1, 2019 - Abstract #TCT2019TCT_238;    
    After propensity score matching, the adjusted 1-year rate of TVF (adjusted HR: 1.020; 95% CI: 0.767 to 1.356; p = 0.892) was similar between 2 groups. There are no significant interactions in key subgroup analysis.UnivariateMultivariatePropensity MatchingTVF1.134 (0.917–1.401)0.999 (0.775–1.288)1.020 (0.767–1.356)Cardiac death0.952 (0.536–1.691)0.488 (0.209–1.137)0.488 (0.195–1.224)Target vessel myocardial infarction1.022 (0.774–1.350)1.098 (0.818–1.474)1.251 (0.900–1.739)Target vessel revascularization1.052 (0.631–1.752)1.026 (0.573–1.837)0.807 (0.415–1.570)Target lesion revascularization1.229 (0.673–2.246)1.008 (0.513–1.979)0.892 (0.419–1.898) Conclusion Among patients who underwent percutaneous coronary intervention, the use of newer R-ZES showed no significantly different outcomes than for the use of DP-EES.
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Clinical, Clinical data, Journal:  Three-year major clinical outcomes of phosphorylcholine polymer- vs biolinx polymer-zotarolimus-eluting stents: A propensity score matching study. (Pubmed Central) -  Sep 5, 2019   
    During the 3-year follow-up period, the cumulative incidence of MACE (hazard ratio [HR], 1.525; 95% confidence interval [CI], 0.920-2.526; P = .101) and ST (HR, 1.248; 95% CI, 0.335-4.4649; P = .741) were similar between P-ZES and B-ZES after PSM. However, TLR rate was significantly higher in ZES-S than ZES-I (11.3% vs 3.8%, log rank P = .029) and TVR rate was higher in ZES-S than ZES-R (14.1% vs 4.8%, log rank P = .025).In this single-center, all-comer registry, despite different polymers, P-ZES, and B-ZES showed comparable safety and efficacy during a 3-year follow-up period after PCI.
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic, Xience (everolimus-eluting stent) / Abbott
    Clinical, Journal:  Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease. (Pubmed Central) -  Jul 19, 2019   
    P=N/A
    In this pooled analysis of 3 prospective registries involving unrestricted use of various second-generation DES for LMCAD, we found no significant between-group differences in 3-year risk of target-vessel failure, except for a higher risk of primary outcome with PtCr-EES compared to BP-BES. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic, Xience (everolimus-eluting stent) / Abbott
    Trial completion date, Trial termination, Real-world evidence, Real-world:  CHOICE: BES, EES, and ZES-R in Real World Practice (clinicaltrials.gov) -  Jul 9, 2019   
    P=N/A,  N=1960, Terminated, 
    Further studies are needed to determine why ZES perform well in this population. Trial completion date: Jun 2019 --> Jan 2019 | Active, not recruiting --> Terminated; Slow enrollment
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Enrollment closed:  RESOLUTE ONYX China RCT Study (clinicaltrials.gov) -  Jun 4, 2019   
    P=N/A,  N=550, Active, not recruiting, 
    Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD. Recruiting --> Active, not recruiting
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Enrollment closed:  RESOLUTE ONYX China Single Arm Study (clinicaltrials.gov) -  Jun 4, 2019   
    P=N/A,  N=591, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial completion, Trial completion date:  RI-US XL: Resolute Integrity US Extended Length Sub-Study(RI US XL) (clinicaltrials.gov) -  May 8, 2019   
    P=N/A,  N=56, Completed, 
    However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes. Active, not recruiting --> Completed | Trial completion date: Oct 2020 --> Dec 2018
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial completion:  Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study (clinicaltrials.gov) -  Apr 3, 2019   
    P=N/A,  N=75, Completed, 
    Recruiting --> Active, not recruiting Active, not recruiting --> Completed
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial completion:  Medtronic Resolute Onyx 2.0 mm Clinical Study (clinicaltrials.gov) -  Apr 3, 2019   
    P=N/A,  N=101, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial primary completion date:  ONYX PAS: RESOLUTE ONYX Post-Approval Study (clinicaltrials.gov) -  Mar 6, 2019   
    P=N/A,  N=510, Recruiting, 
    Trial primary completion date: Jan 2019 --> Sep 2018 Trial primary completion date: Feb 2019 --> Nov 2019
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic, Xience (everolimus-eluting stent) / Abbott
    Trial completion date, Trial primary completion date:  SHEAR-STENT: Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels (clinicaltrials.gov) -  Jan 23, 2019   
    P=N/A,  N=126, Recruiting, 
    Trial primary completion date: Feb 2019 --> Nov 2019 Trial completion date: Dec 2018 --> Jun 2020 | Trial primary completion date: Dec 2018 --> Jun 2020
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial completion date, Trial primary completion date:  The IRIS-Resolute Integrity (IRIS-Integrity) (clinicaltrials.gov) -  Dec 21, 2018   
    P=N/A,  N=3000, Active, not recruiting, 
    Trial completion date: Dec 2018 --> Jun 2020 | Trial primary completion date: Dec 2018 --> Jun 2020 Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Jul 2018 --> Jan 2016
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic
    Trial completion date, Trial primary completion date:  IRIS-Onyx Cohort in the IRIS-DES Registry (clinicaltrials.gov) -  Dec 21, 2018   
    P=N/A,  N=4000, Recruiting, 
    Trial completion date: Dec 2018 --> Dec 2020 | Trial primary completion date: Jul 2018 --> Jan 2016 Trial completion date: Oct 2022 --> Sep 2025 | Trial primary completion date: Oct 2018 --> Sep 2021
  • ||||||||||  Resolute ZES (zotarolimus-eluting stent) / Medtronic, Xience (everolimus-eluting stent) / Abbott
    Phase classification, Enrollment change, Trial withdrawal:  Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents (clinicaltrials.gov) -  Aug 3, 2018   
    P=N/A,  N=0, Withdrawn, 
    Not yet recruiting --> Recruiting Phase classification: P4 --> P=N/A | N=60 --> 0 | Recruiting --> Withdrawn