Coronary Artery DiseaseNCT05621421
The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
An observational study of Coronary Artery Disease, run by Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFR and IVUS guided PCI
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jul 2019to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Vilnius University Hospital Santaros Klinikos
Vilnius, 08410
About this study
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
- Being tested
- FFR and IVUS guided PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR and IVUS guided PCIProcedure or surgery
PCI to the long lesion guided with FFR and IVUS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: FFR and IVUS guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with optimal physiology result
Post PCI FFR value ≥ 0.9
Measured: 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.
Measured: 1 day
The proportion of patients with optimal physiology and anatomy result
Post PCI FFR value ≥ 0.9 and all four IVUS criteria met
Measured: 1 day
Secondary outcomes (1)
The rate of target vessel failure (TVF)
Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), ischemia driven target vessel revascularization (TV-R))
Measured: 12 months post PCI follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Jul 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University
- Responsible party
- Principal investigator, Povilas Budrys, Vilnius University Hospital Santaros Klinikos
- Investigators
- Giedrius Davidavicius, PhD, Prof, Study chair, Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621421
- Sponsor's protocol ID
- 19-C-1252
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT05621421
- Acronym / sponsor ID
- 19-C-1252
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- Vilnius University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with long coronary artery lesions | – | Procedure: FFR and IVUS guided PCIConsecutive patients with functionally significant (FFR ≤ 0.8) long lesion requiring a stent length of ≥ 30mm to undergo FFR and IVUS guided PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR and IVUS guided PCIPCI to the long lesion guided with FFR and IVUS | Procedure or surgery | Patients with long coronary artery lesions |
Primary outcome
The proportion of patients with optimal physiology result
Time frame: 1 day
Post PCI FFR value ≥ 0.9
The proportion of patients with optimal anatomy result
Time frame: 1 day
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.
The proportion of patients with optimal physiology and anatomy result
Time frame: 1 day
Post PCI FFR value ≥ 0.9 and all four IVUS criteria met
1 secondary outcome
The rate of target vessel failure (TVF)
Time frame: 12 months post PCI follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giedrius Davidavicius, PhD, Prof study chair
Vilnius University Hospital Santaros Klinikos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with optimal physiology result (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.