Coronary Artery DiseaseIMAGINATIONNCT06275386
Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
A study testing Paclitaxel Drug-coated balloon in people with Coronary Artery Disease and Total Occlusion of Coronary Artery, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Total Occlusion of Coronary Artery
- What is being tested?
- Paclitaxel Drug-coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 24 Mar 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- native CTO lesion as defined by invasive coronary angiography
- informed consent for participation in the study
Who cannot join
- <18 years of age
- myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy <1 year
- contraindication to PCI
Show all 9Show fewer
- positive pregnancy test or breast-feeding
- in-stent CTO
- CTO recanalization using antegrade or retrograde dissection and re-entry techniques
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
National Institute of Cardiology
Warsaw, Masovian Voivodeship, 04-628
Agnieszka Zdziennicka, azdziennicka@ikard.pl
About this study
Official title: Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.
Read the detailed description
Whereas CTO PCI techniques and success rates have significantly improved during the last decade, CTOs still pose a significant technical challenge for accurate stent sizing (primarily due to negative remodelling and subsequent distal vessel dilatation post-PCI) resulting in a potentially increased risk of stent failure. Hence, the concept of DCB as a definitive treatment for native CTO is appealing and warrants further investigation. The IMAGINATION trial has been designed as a prospective research to: 1) investigate both the immediate and intermediate-term angiographic, IVUS and physiologic efficacy outcomes as well as safety profile of DCB for native vessel coronary CTO, and 2) to provide a basis for future randomized clinical trial comparing DCB to drug-eluting stents.
All patients with CTO will be screened for potential inclusion in the study. After obtaining written informed consent, patients with successful intraplaque guidewire crossing through CTO lesion (excluding the use of dissection and re-entry techniques) will undergo IVUS-guided PCI with a scoring balloon (balloon-to-artery ratio of 1:1) followed by the use of a paclitaxel-coated balloon. Following satisfactory angiographic result, IVUS and physiological measurements (FFR and non-hyperemic pressure ratios) in the target vessel will be performed. At 6-months follow-up, invasive angiography with IVUS and FFR/non-hyperemic pressure ratios in the target vessel will be repeated. In addition, patients with pre-procedural CCTA will undergo follow-up CCTA after 12 months (CCTA substudy).
- Being tested
- Paclitaxel Drug-coated balloon
- Keywords
- chronic total occlusion, percutaneous coronary intervention, drug-coated balloon
- 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.
Paclitaxel Drug-coated balloonDevice
Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | Experimental | Patients will undergo PCI of the native coronary CTO with a DCB. Receives: Device: Paclitaxel Drug-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late lumen loss
The difference by subtracting the minimal lumen diameter (MLD) at follow-up from the MLD postprocedure. In-segment equals DCB plus the proximal and distal 5-mm margins.
Measured: 6-months
Secondary outcomes (8)
Angiographic outcomes assessed directly post-PCI
- minimum lumen diameter (mm)
- residual diameter stenosis (%)
- the rate of bail-out stenting after DCB use (%)
Measured: immediately post-procedure (1 day)
HD-IVUS outcomes assessed directly post-PCI
- minimal lumen diameter (mm)
- minimal lumen area (mm2)
- maximum plaque burden (%)
Measured: immediately post-procedure (1 day)
Physiologic outcomes assessed directly post-PCI
- the ratio of pd/pa
- cRR (absolute values)
- FFR (absolute values)
Measured: immediately post-procedure (1 day)
Angiographic outcomes at 6-months follow-up
- minimum lumen diameter (mm)
- residual diameter stenosis (%)
- in-segment binary restenosis (≥50% diameter stenosis)
- the rate of target vessel re-occlusion (yes/no)
Measured: 6-months
HD-IVUS outcomes at 6-months follow-up
- minimal lumen diameter (mm)
- minimal lumen area (mm2)
- maximum plaque burden (%)
Measured: 6-months
Physiologic outcomes at 6-months follow-up
- the ratio of pd/pa
- cRR (absolute values)
- FFR (absolute values)
Measured: 6-months
Computed tomographic outcomes at 12-months follow-up (CCTA substudy)
- minimal lumen area (mm2)
- maximum plaque burden (%)
- area stenosis (%)
- diameter stenosis (%)
- remodeling index (absolute values)
- total plaque volume (mm3)
- calcified plaque volume (mm3)
- non-calcified plaque volume (mm3)
- low-attenuation plaque volume (mm3)
- percentage of change in in-segment total plaque volume (%)
- percentage of change in in-segment calcified plaque volume (%)
- percentage of change in in-segment non-calcified plaque volume (%)
- percentage of change in in-segment low-attenuation plaque volume (%)
- percentage of change in in-segment remodeling index (%)
Measured: 12-months
Clinical outcomes at 12-months follow-up
- the rate of target lesion failure (composite endpoint of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization)
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start24 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completionMay 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maksymilian Opolski, Principal investigator, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275386
- Sponsor's protocol ID
- 2.31/II/24
- Acronym
- IMAGINATION
- Status last verified
- Oct 2025
- First submitted
- 7 Feb 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention (IMAGINATION)
- ClinicalTrials.gov ID
- NCT06275386
- Acronym / sponsor ID
- IMAGINATION / 2.31/II/24
- Keywords
- chronic total occlusion, percutaneous coronary intervention, drug-coated balloon
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 24 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Feb 2024 (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.
The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO.
Detailed description
Whereas CTO PCI techniques and success rates have significantly improved during the last decade, CTOs still pose a significant technical challenge for accurate stent sizing (primarily due to negative remodelling and subsequent distal vessel dilatation post-PCI) resulting in a potentially increased risk of stent failure. Hence, the concept of DCB as a definitive treatment for native CTO is appealing and warrants further investigation. The IMAGINATION trial has been designed as a prospective research to: 1) investigate both the immediate and intermediate-term angiographic, IVUS and physiologic efficacy outcomes as well as safety profile of DCB for native vessel coronary CTO, and 2) to provide a basis for future randomized clinical trial comparing DCB to drug-eluting stents.
All patients with CTO will be screened for potential inclusion in the study. After obtaining written informed consent, patients with successful intraplaque guidewire crossing through CTO lesion (excluding the use of dissection and re-entry techniques) will undergo IVUS-guided PCI with a scoring balloon (balloon-to-artery ratio of 1:1) followed by the use of a paclitaxel-coated balloon. Following satisfactory angiographic result, IVUS and physiological measurements (FFR and non-hyperemic pressure ratios) in the target vessel will be performed. At 6-months follow-up, invasive angiography with IVUS and FFR/non-hyperemic pressure ratios in the target vessel will be repeated. In addition, patients with pre-procedural CCTA will undergo follow-up CCTA after 12 months (CCTA substudy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | Experimental | Device: Paclitaxel Drug-coated balloonPatients will undergo PCI of the native coronary CTO with a DCB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or viability)
- native CTO lesion as defined by invasive coronary angiography
- informed consent for participation in the study
Key exclusion criteria (9 listed)
- <18 years of age
- myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy <1 year
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 |
|---|---|---|
| Paclitaxel Drug-coated balloonPercutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon. | Device | Drug-coated balloon |
Primary outcome
In-segment late lumen loss
Time frame: 6-months
The difference by subtracting the minimal lumen diameter (MLD) at follow-up from the MLD postprocedure. In-segment equals DCB plus the proximal and distal 5-mm margins.
8 secondary outcomes
Angiographic outcomes assessed directly post-PCI
Time frame: immediately post-procedure (1 day)
HD-IVUS outcomes assessed directly post-PCI
Time frame: immediately post-procedure (1 day)
Physiologic outcomes assessed directly post-PCI
Time frame: immediately post-procedure (1 day)
Angiographic outcomes at 6-months follow-up
Time frame: 6-months
HD-IVUS outcomes at 6-months follow-up
Time frame: 6-months
Physiologic outcomes at 6-months follow-up
Time frame: 6-months
Computed tomographic outcomes at 12-months follow-up (CCTA substudy)
Time frame: 12-months
Clinical outcomes at 12-months follow-up
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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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.
Maksymilian Opolski principal investigator
National Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Drug-coated balloon in people with Coronary Artery Disease and Total Occlusion of Coronary Artery, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 9 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maksymilian Opolski (0048(22)3434127, mopolski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment late lumen loss (time frame: 6-months). 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 2 Jan 2026.