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

NCT05205148 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-01-24

No results posted yet for this study

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.

Conditions

  • Coronary Artery Disease
  • Coronary Stenosis
  • Stent Restenosis
  • Left Main Coronary Artery Disease
  • Chronic Total Occlusion of Coronary Artery

Interventions

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

Sponsors & Collaborators

  • A.O.U. Città della Salute e della Scienza

    lead OTHER

Principal Investigators

  • Fabrizio D'Ascenzo, PhD · AOU Città della salute e della scienza torino

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-04-30
Completion
2024-12-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205148 on ClinicalTrials.gov