The TICO trial was a multicenter randomized trial and included the 3056 patients with ACS who underwent PCI with ultrathin bioresorbable polymer sirolimus‐eluting stents (Orsiro; Biotronik AG, Bülach, Switzerland). More detailed inclusion and exclusion criteria have been previously published.5 The trial was approved by the institutional review board at each center and was performed in accordance with the principles of the Declaration of Helsinki. All participants provided written informed consent before participation in the trial. In the TICO trial, patients were randomly assigned 1:1 to receive either ticagrelor monotherapy after 3‐month DAPT or ticagrelor‐based 12‐month DAPT after DES implantation. Clinical follow‐up was completed for all except 78 patients, of whom 48 were lost to follow‐up and 30 withdrew consent.
Orsiro
Manufactured by Biotronik
Sourced in Switzerland, Germany
The Orsiro is a lab equipment product manufactured by Biotronik. It is a medical device designed for use in various laboratory settings. The core function of the Orsiro is to provide a reliable and precise instrument for specific laboratory procedures, but a detailed description while maintaining an unbiased and factual approach is not available.
Automatically generated - may contain errors
Lab products found in correlation
Resolute onyx, by Medtronic (4 mentions)
Xience, by Abbott (4 mentions)
Promus, by Boston Scientific (2 mentions)
Endeavor resolute, by Medtronic (1 mentions)
Nobori, by Terumo (1 mentions)
Ultimaster, by Terumo (1 mentions)
Resolute integrity, by Medtronic (1 mentions)
Magmaris, by Biotronik (1 mentions)
Sequent please, by B. Braun (1 mentions)
Xience alpine, by Abbott (1 mentions)
Sequent please neo, by B. Braun (1 mentions)
Xience prime, by Abbott (1 mentions)
Xience prime xpedition, by Abbott (1 mentions)
Crestor, by AstraZeneca (1 mentions)
13 protocols using orsiro
1
Ticagrelor Monotherapy After PCI with DES
2
Stent Implantation with Second-Generation DES
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Stent implantation was performed according to current standard techniques and medical guidelines. A total of 1245 lesions were treated with second-generation DESs: 425 everolimuseluting (Xience, Abbot Vascular, Santa Clara, CA, USA; and Promus, Boston Scientific, Marlborough, MA, USA), 399 zotarolimus-eluting (Endeavor Resolute, Medtronic, Minneapolis, MN, USA), 89 sirolimus-eluting (Orsiro, Biotronik, Berlin, Germany), and 332 biolimus-eluting (BioMatrix, Biosensors International, Singapore; and Nobori, Terumo, Tokyo, Japan) stents were used.
All patients were given 300 mg of aspirin in addition to 300 mg to 600 mg of clopidogrel, 180 mg of ticagrelor, or 60 mg of prasugrel before their procedure and were maintained on dual-antiplatelet therapy after DES implantation for at least 6 months. During the intervention, unfractionated heparin was administered to maintain an activated clotting time of more than 250 seconds. Specific details of the intervention, such as lesion predilatation, poststent dilation, and the application of mechanical support or concomitant medication, were left to the discretion of the operator.
All patients were given 300 mg of aspirin in addition to 300 mg to 600 mg of clopidogrel, 180 mg of ticagrelor, or 60 mg of prasugrel before their procedure and were maintained on dual-antiplatelet therapy after DES implantation for at least 6 months. During the intervention, unfractionated heparin was administered to maintain an activated clotting time of more than 250 seconds. Specific details of the intervention, such as lesion predilatation, poststent dilation, and the application of mechanical support or concomitant medication, were left to the discretion of the operator.
3
Comparison of BiOSS LIM C and DES in Bifurcation PCI
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Five hundred eighteen patients with symptomatic stable coronary artery disease or NSTE-ACS qualified for PCI in non-LM coronary bifurcation will be screened, and enrolled if informed consent form is signed and all inclusion criteria and none exclusion criteria are met. Inclusion criteria and exclusion criteria are detailed in Table 1 .
Subjects will be 1:1 randomized to a BiOSS LIM C stent versus DES group. The following DES will be allowed: Xience (Abbott Laboratories, Chicago, IL), Resolute Onyx (Medtronic, Dublin, Ireland), Orsiro (Biotronik, Berlin, Germany), and Synergy (Boston Scientific, Marlborough, MA). Patients will be followed, according to the protocol (ClinicalTrials.gov NCT03548272) (Fig.1 ). Study protocol is compliant with SPIRIT guidelines.[13 (link)] Independent Ethics Committee approved the study protocol (No. 14/2018).
Subjects will be 1:1 randomized to a BiOSS LIM C stent versus DES group. The following DES will be allowed: Xience (Abbott Laboratories, Chicago, IL), Resolute Onyx (Medtronic, Dublin, Ireland), Orsiro (Biotronik, Berlin, Germany), and Synergy (Boston Scientific, Marlborough, MA). Patients will be followed, according to the protocol (ClinicalTrials.gov NCT03548272) (Fig.
4
Comparative Analysis of Drug-Eluting Stents
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
The second-and third-generation DESs were defined as everolimus-eluting stents with a durable polymer (Xience [Abbott Vascular, Santa Clara, California] and Promus [Boston Scientific, Natick, Massachusetts]), zotarolimus-eluting stents with a durable polymer (Resolute [Medtronic, Minneapolis, Minnesota]), everolimus-eluting stents with a bioabsorbable polymer (Synergy [Boston Scientific, Natick, Massachusetts]), biolimus-eluting stents with a biodegradable polymer (Nobori [Terumo, Tokyo, Japan]), Ultimaster sirolimus-eluting stents with a biodegradable polymer (Ultimaster [Terumo, Tokyo, Japan] and Orsiro [Biotronik, Bülach, Switzerland]), Biomatrix biolimus A9 (BA9)-eluting stents with a biodegradable polymer, and BioFreedom BA9-coated stents (Biosensors, Newport Beach, California) [3 (link)].
5
Ticagrelor vs. Clopidogrel in STEMI Patients
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Eligible patients were randomly assigned in a 1:1 ratio to receive either ticagrelor or clopidogrel, using an interactive webbased response system with a permuted block randomisation method. The patients received aspirin (300 mg as a loading dose or 100 mg if previously administered) and a loading dose of the study drug (180 mg of ticagrelor or 300 to 600 mg of clopidogrel) before PCI. All patients with ST-elevation AMI underwent primary PCI. For revascularisation of culprit lesions, only thin-strut biodegradable polymer sirolimus-eluting stent (Orsiro; Biotronik AG, Bülach, Switzerland) was allowed. Operator was able to use OCT imaging before or after stent implantation, if clinically needed. Operator evaluated OCT findings during the procedure, and decided to use further adjuvant ballooning for stent optimization. Final OCT (post-procedural) was performed at the treated culprit before completing the procedure. Patients took aspirin and study drug as allocated without cross-over during the study period, and underwent 3-month
follow-up OCT.
follow-up OCT.
6
Ultrathin Biodegradable vs. Durable Polymer DES
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
In the BIO-RESORT and BIONYX randomized trials, new-generation ultrathin-strut biodegradable polymer SES (Orsiro; Biotronik, Bülach, Switzerland) were compared with thin-strut durable polymer ZES (Resolute Integrity and Resolute Onyx, respectively; Medtronic, Santa Rosa, California, USA). The ultrathin-strut BP-SES releases the drug during slightly more than 3 months. Its poly(L-lactide) acid (PLLA) coating, which is resorbed during approximately 2 years, is more than twice as thick on the abluminal strut side (7.4 µm, compared to 3.5 µm luminal). Its metallic backbone is made from 60 µm cobalt-chromium struts in stents with a nominal diameter of less than 3.5 mm; in larger stents, strut thickness is 80 µm. DP-ZES release zotarolimus during a period of 6 months from a conformal (thickness 5.6 µm) durable polymer layer—the BioLinx polymer system. The Resolute Integrity ZES has round struts made from cobalt-chromium and the Resolute Onyx ZES has roundish (ellipsoid) struts made from cobalt-chromium with a platinum-iridium core. Both DP-ZES have thin-struts with a strut thickness of 81 µm in Resolute Onyx ZES <3.0 mm and 91 µm in larger Resolute Onyx ZES and in all Resolute Integrity ZES. Further technical details of the DES are presented in Table S1 .
7
Randomized Biolimus A9 vs. Sirolimus Stent Trial
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
The investigators enrolled the patients who were randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by center (permuted blocks of random sizes [2/4/6]) was used to assign patients in a 1:1 ratio to receive the biolimus A9-coated BioFreedom, a stainless steel drug-coated stent (Biosensors, Morges, Switzerland) or the biodegradable polymer sirolimus-eluting stent (Orsiro; Biotronik, Bülach, Switzerland). The allocation sequence, stratified by sex and presence of diabetes mellitus, was computer-generated by an independent organization. Patients were assigned to treatment through a web-based Trial Partner randomization system. All individuals who analyzed the data
8
Comparative Study of Drug-Eluting Stents
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
Table S2 summarizes the stent characteristics of the study devices. In brief, the following 6 different types of DESs were investigated: durable‐polymer everolimus‐eluting stent (EES; Xience, Abbott Vascular, Santa Clara, CA), bioresorbable‐polymer sirolimus‐eluting stent (SES; Orsiro, Biotronik, Baar, Switzerland), polymer‐free biolimus‐eluting stent (BES; Biofreedom, Biosensors, Morges, Switzerland), bioactive endothelial progenitor cell–capturing SES (Combo, OrbusNeich, Hoevelaken, the Netherlands), poly‐L‐lactide (PLLA)–based everolimus BRS (Absorb stents, Abbott Vascular, Santa Clara, CA), and Mg‐based sirolimus BRS (Magmaris, Biotronik).
9
Radial Approach PCI Techniques
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
A 6F right radial approach has been selected whenever possible. During PCI, patients were anticoagulated with unfractionated heparin (a bolus of 40 U/kg and additional heparin to achieve an activated clotting time of 250–300 s). The selection of stenting techniques was left to operator choice and included provisional stenting, Culotte, T-and-Protrusion (TAP), and Nano-inverted-T stenting. Patients could receive the Orsiro (Biotronik Inc., Bulach, Switzerland), Xience (Abbot Inc., Abbot Park, IL, USA) and Promus Premiere (Boston Scientific Inc., Marlborough, MA, USA) or the Onyx Resolute (Medtronic Inc., Galway, Ireland) stents, basing the diameter of the main vessel stent on Finet’s law [12 (link)], or preferably IVUS, which was recommended in all enrolled patients whenever possible, depending on availability. The kissing balloon was considered mandatory in all double stent techniques, whereas in provisional stenting, the preferred strategy was POT or POT-Side-POT technique. Additional significant lesions in other vessels were treated with staged procedures and a routine last generation DES of the operator’s choice. Twelve-month Ticagrelor or Prasugrel treatment or 12-month Clopidogrel 75 mg in case of excessive bleeding risk or frailty and life-long aspirin was recommended to all patients according to our regional guidelines.
10
Comparison of Small Vessel DCBs and DESs
Check if the same lab product or an alternative is used in the 5 most similar protocols
+ Expand
The available DCBs at our institution with nominal diameters of 2.0 mm and 2.25 mm for very small vessel lesions were SeQuent Please, SeQuent Please Neo (B. Braun, Berlin, Germany), and Agent (Boston Scientific, Wurselen, Germany). The available DESs with stent diameters of 2.0 mm and 2.25 mm for very small vessel lesions were sirolimus-eluting Orsiro (Biotronik, Buloch, Switzerland), everolimus-eluting Synergy (Boston Scientific, Galway, Ireland), Xience Alpine (Abbott Vascular, Tipperary, Ireland), and zotarolimus-eluting Resolute Onyx (Medtronic, Galway, Ireland). The choice of device was left to the operator or according to the patient’s preference.
About PubCompare
Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.
We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.
However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.
Ready to get started?
Sign up for free.
Registration takes 20 seconds.
Available from any computer
No download required
Revolutionizing how scientists
search and build protocols!