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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-12-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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