The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions

NCT ID: NCT05621421

Last Updated: 2022-11-18

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

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-03-31

Brief Summary

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A single center, prospective, observational study to investigate the impact of intravascular ultrasound (IVUS) on the functional percutaneous coronary intervention (PCI) result (assessed with fractional flow reserve (FFR)) and one-year target vessel failure (TVF) rate after percutaneous treatment of long coronary artery lesions

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with long coronary artery lesions

Consecutive patients with functionally significant (FFR ≤ 0.8) long lesion requiring a stent length of ≥ 30mm to undergo FFR and IVUS guided PCI.

FFR and IVUS guided PCI

Intervention Type PROCEDURE

PCI to the long lesion guided with FFR and IVUS

Interventions

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FFR and IVUS guided PCI

PCI to the long lesion guided with FFR and IVUS

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation);
* Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation);
* Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention.

Exclusion Criteria

* Patient's age ≤ 18 years;
* Acute myocardial infarction with ST segment elevation;
* Treatment with dual antiplatelet therapy contraindicated;
* Survival expectancy ≤ 1 year;
* Known allergy to sirolimus, everolimus or zotarolimus.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vilnius University

OTHER

Sponsor Role collaborator

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role lead

Responsible Party

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Povilas Budrys

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giedrius Davidavicius, PhD, Prof

Role: STUDY_CHAIR

Vilnius University Hospital Santaros Klinikos

Locations

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Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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19-C-1252

Identifier Type: -

Identifier Source: org_study_id

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