Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05205148
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 13.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Stenosis; Stent Restenosis; Left Main Coronary Artery Disease; Chronic Total Occlusion of Coronary Artery	Device: Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Ultrathin Drug Eluting Stents for Patients With Left-main, bifurcaTion, chRonic totAl Occlusion, or In-stent Restenosis Coronary Lesion in Real Life: the ULTRA a Multicenter Study
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Dec 30, 2024

Outcome Measures

Primary Outcome Measures

1. Incidence of target lesion failure (TLF) [Up to 2 years]

   A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis

Secondary Outcome Measures

1. Incidence of all-cause death [Up to 2 years]

   death from any cause

2. Incidence of acute myocardial infarction (AMI) [Up to 2 years]

   all acute myocardial infarction excluding peri-procedural myocardial infarction

3. Incidence of target vessel revascularization (TVR) [Up to 2 years]

   All revascularization in a vessel treated with ultrathin DES within the index procedure

4. Incidence of major bleedings [Up to 2 years]

   Major bleedings defined according to Bleeding Academic Research Consortium (BARC 3-5)

5. Incidence of cardiovascular death [Up to 2 years]

   Death from cardiovascular causes

6. Incidence of target Vessel Myocardial Infarction [Up to 2 years]

   Myocardial infarction whose culprit artery is unequivocally identified as an artery treated with ultrathin Drug eluting stent within the index procedure

7. Incidence of target lesion revascularization [Up to 2 years]

   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

8. Incidence of definite stent thrombosis [Up to 2 years]

   stent thrombosis in a coronary segment previously treated with ultrathin drug eluting stent

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fabrizio D'Ascenzo	Torino		Italy	10126

Sponsors and Collaborators

• Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

• Principal Investigator: Fabrizio D'Ascenzo, PhD, AOU Città della salute e della scienza torino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fabrizio D'Ascenzo, Clinical Professor, Azienda Ospedaliera Città della Salute e della Scienza di Torino
• ClinicalTrials.gov Identifier: NCT05205148
• Other Study ID Numbers: ULTRA registry
• First Posted: Jan 24, 2022
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis

Study Results

No Results Posted as of Jan 24, 2022