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New treatment option for Coronary Artery Disease
Official title Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT06275386
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- clinical indication for CTO PCI as determined by the local heart team (presence of angina or equivalent symptoms and/or documented ischemia or...
- native CTO lesion as defined by invasive coronary angiography
- informed consent for participation in the study
You likely can't join if
- \<18 years of age
- myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy \<1 year
- contraindication to PCI
See the full eligibility criteria
- 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
- \<18 years of age
- myocardial infarction
- cardiogenic shock
- severe valvular disease
- estimated life expectancy \<1 year
- contraindication to PCI
- positive pregnancy test or breast-feeding
- in-stent CTO
- CTO recanalization using antegrade or retrograde dissection and re-entry techniques
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.