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Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention

ConditionsCoronary Artery DiseaseTotal Occlusion of Coronary Artery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute of Cardiology, Warsaw, Poland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

<18 years of age

myocardial infarction

cardiogenic shock

severe valvular disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Paclitaxel Drug-coated balloon

    Device

    Percutaneous coronary intervention of the actual CTO body with a paclitaxel drug-coated balloon.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Drug-coated balloonExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6-months

Secondary outcomes

1

Angiographic outcomes assessed directly post-PCI

* minimum lumen diameter (mm) * residual diameter stenosis (%) * the rate of bail-out stenting after DCB use (%)

Time frame
immediately post-procedure (1 day)
2

HD-IVUS outcomes assessed directly post-PCI

* minimal lumen diameter (mm) * minimal lumen area (mm2) * maximum plaque burden (%)

Time frame
immediately post-procedure (1 day)
3

Physiologic outcomes assessed directly post-PCI

* the ratio of pd/pa * cRR (absolute values) * FFR (absolute values)

Time frame
immediately post-procedure (1 day)
4

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)

Time frame
6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Cardiology, Warsaw, Poland

Lead sponsor

Source ClinicalTrials.gov
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