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ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz | Device | Patients treated with ultrathin coronary stents (namely stents with strut thickness < 70 um) for specific coronary disease scenarios: unprotected left main stenosis; Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm); Chronic total coronary occlusion; In-stent restenosis |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of target lesion failure (TLF) | A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all-cause death | death from any cause | Up to 2 years |
| Incidence of acute myocardial infarction (AMI) | all acute myocardial infarction excluding peri-procedural myocardial infarction |
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Inclusion Criteria:
Treated with the following devices:
Exclusion Criteria:
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Consecutive patients treated with ultrathin coronary DES for coronary bifurcation lesions, left main disease, chronic total coronary occlusion and in-stent restenosis regardless of their clinical presentation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ovidio De Filippo, MD | Contact | +390116336023 | ovidio.defilippo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fabrizio D'Ascenzo, PhD | AOU Città della Salute e della Scienza Torino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabrizio D'Ascenzo | Recruiting | Torino | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39895551 | Derived | Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3. | |
| 39492702 |
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| Up to 2 years |
| Incidence of target vessel revascularization (TVR) | All revascularization in a vessel treated with ultrathin DES within the index procedure | Up to 2 years |
| Incidence of major bleedings | Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5) | Up to 2 years |
| Incidence of cardiovascular death | Death from cardiovascular causes | Up to 2 years |
| Incidence of target Vessel Myocardial Infarction | Myocardial infarction whose culprit artery is unequivocally identified as an artery treated with ultrathin Drug eluting stent within the index procedure | Up to 2 years |
| Incidence of target lesion revascularization | coronary revascularization due to acute coronary syndrome or stable ischemic presentation due to a lesion previously treated with ultrathin drug eluting stent within the index procedure | Up to 2 years |
| Incidence of definite stent thrombosis | stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent | Up to 2 years |
| Derived |
| De Filippo O, Wanha W, Sanavia T, Januszek R, Giacobbe F, Campo G, Pinxterhuis TH, Capodanno D, Tomasiewicz B, Iannaccone M, Leone A, Wolny R, Bruno F, Patti G, Musumeci G, Liccardo G, Verardi R, Roubin SR, Tarantini G, Kuzma L, Perl L, Gagnor A, Reczuch K, Conrotto F, Tuttolomondo D, Ploumen EH, Niezgoda P, Caglioni S, Omede P, Greco A, Kubica J, Gil RJ, Piccolo R, Kornowski R, Bil J, Morena A, Zocca P, Pennone M, Gasior M, Jaguszewski M, von Birgelen C, Fariselli P, De Ferrari GM, Wojakowski W, D'Ascenzo F. Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry. EuroIntervention. 2024 Nov 4;20(21):e1340-e1354. doi: 10.4244/EIJ-D-24-00491. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| 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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