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

NCT05621421 | Completed

• 1 other identifier: 19-C-1252
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• The proportion of patients with optimal physiology result

  Post PCI FFR value ≥ 0.9

  1 day

• The proportion of patients with optimal anatomy result

  If all the four following IVUS criteria met: (1) good stent apposition; (2) good stent expansion (minimal stent area (MSA) \>90% of distal reference lumen area and/or MSA ≥5.5mm2); (3) plaque burden 5mm proximal and distal to the stent \<50%); (4) no stent edge dissection.

  1 day

• The proportion of patients with optimal physiology and anatomy result

  Post PCI FFR value ≥ 0.9 and all four IVUS criteria met

  1 day

Secondary Outcomes (1)

• The rate of target vessel failure (TVF)

  12 months post PCI follow up

Study Arms (1)

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.

Procedure: FFR and IVUS guided PCI

Interventions

FFR and IVUS guided PCI PROCEDURE

PCI to the long lesion guided with FFR and IVUS

Patients with long coronary artery lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University Hospital Santaros Klinikos: lead
• Vilnius University: collaborator

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, 08410, Lithuania

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Giedrius Davidavicius, PhD, Prof

  Vilnius University Hospital Santaros Klinikos

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 18, 2022
• Study Start: July 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

LI (1)