Coronary Artery DiseaseNCT05732324
Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Vilnius University Hospital Santaros Klinikos.
Trial summary
A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the 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, Myocardial Ischemia, Myocardial Infarction
- What is being tested?
- IVUS guided PCI optimization, FFR guided PCI optimization and FFR measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2012to 31 Mar 2022
- 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
- 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.
About this study
A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the treatment of long coronary artery lesions.
- Being tested
- IVUS guided PCI optimization, FFR guided PCI optimization, FFR measurement
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS guided PCI optimizationProcedure or surgery
PCI to long lesion will be optimized according to the IVUS.
FFR guided PCI optimizationProcedure or surgery
PCI to long lesion will be optimized according to the FFR.
FFR measurementDiagnostic test
Fractional flow reserve protocol will be applied for both FFR-guided and IVUS-guided PCI groups. FFR will be measured according to the standard practice using intravenous adenosine. FFR will be recorded before PCI at the distal third of the coronary artery and after PCI at the same location. In FFR optimization group more than one post PCI FFR measurements could be acquired if the operators performed additional optimization. In IVUS optimization group only one post PCI FFR measurement will be recorded after which the procedure will be considered to be finished, and no further interventions will be undertaken. The same FFR measurements will be performed at 9-12 months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| IVUS PCI optimization group | PCI will be optimized according to the IVUS. IVUS will be performed before PCI and will be used to select PCI strategy.
Operators will try to reach an optimal anatomical PCI result as assessed by IVUS aiming for the following criteria:
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.
After stent optimization an IVUS run will be performed. The IVUS run will be considered as final when further anatomical optimization will not be thought to be possible. Receives: Procedure: IVUS guided PCI optimization; Diagnostic Test: FFR measurement | |
| Historical FFR PCI optimization group | The goal will be to achieve the optimal functional result, defined as an FFR post PCI ≥ 0.95. Further stented segment post-dilatation will be mandatory if FFR post PCI < 0.95. In case of a clear evidence of significant atheroma proximal or distal to the stented segment, the operators will be encouraged to optimize the functional result further by implanting additional stents. Receives: Procedure: FFR guided PCI optimization; Diagnostic Test: FFR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of optimal functional PCI result
Post PCI FFR value < 0.9
Measured: One year
The rate of poor functional PCI result
Post PCI FFR value ≤ 0.8
Measured: One year
The rate of optimal anatomical PCI 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
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), any target vessel revascularization (TV-R))
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Sep 2012
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 154 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
- NCT05732324
- Sponsor's protocol ID
- 19C1252
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 22 Feb 2023
- 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Percutaneous Coronary Intervention Optimization With Fractional Flow Reserve Versus Intravascular Ultrasound in the Treatment of Long Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT05732324
- Acronym / sponsor ID
- 19C1252
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- Vilnius University
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Feb 2023 (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 compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the treatment of long coronary artery lesions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS PCI optimization group | – | Procedure: IVUS guided PCI optimization, Diagnostic Test: FFR measurementPCI will be optimized according to the IVUS. IVUS will be performed before PCI and will be used to select PCI strategy. Operators will try to reach an optimal anatomical PCI result as assessed by IVUS aiming for the following criteria: 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. After stent optimization an IVUS run will be performed. The IVUS run will be considered as final when further anatomical optimization will not be thought to be possible. |
| Historical FFR PCI optimization group | – | Procedure: FFR guided PCI optimization, Diagnostic Test: FFR measurementThe goal will be to achieve the optimal functional result, defined as an FFR post PCI ≥ 0.95. Further stented segment post-dilatation will be mandatory if FFR post PCI < 0.95. In case of a clear evidence of significant atheroma proximal or distal to the stented segment, the operators will be encouraged to optimize the functional result further by implanting additional stents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| IVUS guided PCI optimizationPCI to long lesion will be optimized according to the IVUS. | Procedure or surgery | IVUS PCI optimization group |
| FFR guided PCI optimizationPCI to long lesion will be optimized according to the FFR. | Procedure or surgery | Historical FFR PCI optimization group |
| FFR measurementFractional flow reserve protocol will be applied for both FFR-guided and IVUS-guided PCI groups. FFR will be measured according to the standard practice using intravenous adenosine. FFR will be recorded before PCI at the distal third of the coronary artery and after PCI at the same location. In FFR optimization group more than one post PCI FFR measurements could be acquired if the operators performed additional optimization. In IVUS optimization group only one post PCI FFR measurement will be recorded after which the procedure will be considered to be finished, and no further interventions will be undertaken. The same FFR measurements will be performed at 9-12 months follow-up. | Diagnostic test | Historical FFR PCI optimization group, IVUS PCI optimization group |
Primary outcome
The rate of optimal functional PCI result
Time frame: One year
Post PCI FFR value < 0.9
The rate of poor functional PCI result
Time frame: One year
Post PCI FFR value ≤ 0.8
The rate of optimal anatomical PCI 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.
1 secondary outcome
The rate of target vessel failure (TVF)
Time frame: One year
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 22 Feb 2023.
- 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
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Vilnius University Hospital Santaros Klinikos.
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 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 rate of optimal functional PCI result (time frame: One year). 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 22 Feb 2023.