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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05205148
Other study ID # ULTRA registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2024

Study information

Verified date January 2022
Source Azienda Ospedaliera Città della Salute e della Scienza di Torino
Contact Ovidio De Filippo, MD
Phone +390116336023
Email ovidio.defilippo@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 30, 2024
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - age > 18 years old - Unprotected left main stenosis - Bifurcation coronary stenosis (with side branch diameter = 2.5 mm) - Chronic total coronary occlusion - In-stent restenosis Treated with the following devices: - Orsiro - Mistent - BioMime - Supraflex Cruz Exclusion Criteria: - patients died during the index revascularization procedure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
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

Locations

Country Name City State
Italy Fabrizio D'Ascenzo Torino

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Incidence of all-cause death death from any cause Up to 2 years
Secondary Incidence of acute myocardial infarction (AMI) all acute myocardial infarction excluding peri-procedural myocardial infarction Up to 2 years
Secondary Incidence of target vessel revascularization (TVR) All revascularization in a vessel treated with ultrathin DES within the index procedure Up to 2 years
Secondary Incidence of major bleedings Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5) Up to 2 years
Secondary Incidence of cardiovascular death Death from cardiovascular causes Up to 2 years
Secondary 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
Secondary 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
Secondary Incidence of definite stent thrombosis stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent Up to 2 years
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