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Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent.
Prospective registry intended to evaluate clinical outcomes of ihtDEStiny drug eluting coronary stent use in real-world percutaneous coronary intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Device | stenting with the ihtDEStiny® sirolimus eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Rate of target lesion failure | 2 years |
| Target Lesion Failure (TLF) | Rate of target lesion failure | 5 years |
| Death | Death | 2 years |
| Death | Death | 5 years |
| Target vessel myocardial infarction | Target vessel myocardial infarction | 2 years |
| Target vessel myocardial infarction | Target vessel myocardial infarction | 5 years |
| Target lesion revascularization (TLR) | Target lesion revascularization (TLR) | 2 years |
| Target lesion revascularization (TLR) | Target lesion revascularization (TLR) | 5 years |
| Cardiovascular Death | Cardiovascular Death | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | Stent thrombosis | 2 years |
| Stent thrombosis | Stent thrombosis | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with all inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Universitario Do Algarbe | Faro | 8000-386 | Portugal | |||
| Hospital Universitario Regional de Malaga Carlos Haya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33060037 | Background | de la Torre Hernandez JM, Ocaranza Sanchez R, Santas Alvarez M, Pinar Bermudez E, Hurtado Martinez JA, Garcia Del Blanco B, Otaegui I, Fernandez Nofrerias E, Carrillo Suarez X, Sainz Laso F, Casanova Sandoval JM, Rivera Aguilar PK, Cid B, Trillo R, Lozano Ruiz-Poveda F, Peral Disdier V, Telleria M, Torres A, Sanchis J, Oliva X, Freixa X, Sadaba Sagredo M, Moreu J, Hernandez F. Comparison of One-Year Outcomes Between the ihtDEStiny BD Stent and the Durable-Polymer Everolimus- and Zotarolimus-Eluting Stents: A Propensity-Score-Matched Analysis. Cardiovasc Revasc Med. 2021 Oct;31:1-6. doi: 10.1016/j.carrev.2020.09.046. Epub 2020 Oct 3. | |
| 33386256 |
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| Cardiovascular Death | Cardiovascular Death | 5 years |
| Target Vessel Failure (TVF) | Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR) | 2 years |
| Target Vessel Failure (TVF) | Composite event of cardiovascular (CV) death, target vessel myocardial infarction (MI) and target vessel revascularization (TVR) | 5 years |
| Major Adverse Cardiovascular Event (MACE) | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke | 2 years |
| Major Adverse Cardiovascular Event (MACE) | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke | 5 years |
| Patient Oriented Composite Event | Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization | 2 years |
| Patient Oriented Composite Event | Composite event of death, non-fatal myocardial infarction (MI), non-fatal stroke or any revascularization | 5 years |
| Severe BARC Bleeding | BARC Bleeding ≥3 | 2 years |
| Severe BARC Bleeding | BARC Bleeding ≥3 | 5 years |
| Device success | residual coronary stenosis<50%, normal coronary flow and absence of coronary dissection ≥C | During procedure |
| Procedural success | Device success and absence of PCI complication (periprocedural MI, coronary perforation, urgent CABG or death) or revascularization within 3 days | 3 days |
| Málaga |
| Malaga |
| 29010 |
| Spain |
| Hospital Universitario de Cruces | Barakaldo | 48903 | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital San Pedro de Alcantara | Cáceres | 10003 | Spain |
| Hospital General Universitario de Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital General Universitario de Elche | Elche | 03203 | Spain |
| Hospital de Galdakao | Galdakao | 48960 | Spain |
| Hospital Universitario Juan Ramon Jimenez | Huelva | 21005 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | 25198 | Spain |
| Hospital Universitario Lucus Agusti | Lugo | 27003 | Spain |
| Hospital Universitario Virgen de La Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Arrixaca | Murcia | 30120 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | 15706 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario de Araba | Vitoria-Gasteiz | 01009 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Background |
| de la Torre Hernandez JM, Otaegui I, Subinas A, Gomez-Menchero A, Moreno R, Rondan J, Munoz-Garcia E, Sainz-Laso F, Garcia Del Blanco B, Rumoroso JR, Diaz JF, Berenguer A, Gomez-Lara J, Zueco J. First-in-Man Evaluation of a Sirolimus-Eluting Stent With Abluminal Fluoropolymeric/Triflusal Coating With Ultrathin Struts by OCT at 9 Months' Follow-Up: The PROMETHEUS Study. Cardiovasc Revasc Med. 2021 Nov;32:18-24. doi: 10.1016/j.carrev.2020.12.025. Epub 2020 Dec 29. |
| 31422087 | Background | Buiten RA, Ploumen EH, Zocca P, Doggen CJM, Danse PW, Schotborgh CE, Scholte M, van Houwelingen KG, Stoel MG, Hartmann M, Tjon Joe Gin RM, Somi S, Linssen GCM, Kok MM, von Birgelen C. Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1650-1660. doi: 10.1016/j.jcin.2019.04.054. Epub 2019 Aug 14. |
| 28279314 | Background | El-Hayek G, Bangalore S, Casso Dominguez A, Devireddy C, Jaber W, Kumar G, Mavromatis K, Tamis-Holland J, Samady H. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents. JACC Cardiovasc Interv. 2017 Mar 13;10(5):462-473. doi: 10.1016/j.jcin.2016.12.002. |
| 30292330 | Background | Iantorno M, Lipinski MJ, Garcia-Garcia HM, Forrestal BJ, Rogers T, Gajanana D, Buchanan KD, Torguson R, Weintraub WS, Waksman R. Meta-Analysis of the Impact of Strut Thickness on Outcomes in Patients With Drug-Eluting Stents in a Coronary Artery. Am J Cardiol. 2018 Nov 15;122(10):1652-1660. doi: 10.1016/j.amjcard.2018.07.040. Epub 2018 Sep 8. |
| 40713212 | Derived | Linares Vicente JA, Sainz Laso F, Casanova Sandoval JM, Rumoroso Cueva JR, Gomez Menchero A, Gomez Hospital JA, Perez Guerrero A, Santos Martinez S, Fernandez Portales J, Romani S, Garcia Del Blanco B, Ocaranza Sanchez R, Urbano Carrillo C, Garcia San Roman K, Vinhas H, Cid Alvarez B, Sanchis Fores J, Telleria Arrieta M, Torres Bosco A, Pinar Bermudez E, Mendez Castro JJ, Lozano Ruiz de Poveda F, Perez de Prado A, De la Torre Hernandez JM. Long-term outcomes of hydrodynamic ultra-thin strut sirolimus-eluting stent with fluoropolymer containing triflusal: VELAZQUEZ-EPIC26 study. Cardiovasc Revasc Med. 2026 Mar;84:26-33. doi: 10.1016/j.carrev.2025.07.009. Epub 2025 Jul 17. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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