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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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). 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
National Institute of Cardiology
RECRUITING
Warsaw
Contact Information
Primary
Maksymilian Opolski
mopolski@ikard.pl
0048(22)3434127
Time Frame
Start Date: 2024-03-24
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 30
Treatments
Experimental: Drug-coated balloon
Patients will undergo PCI of the native coronary CTO with a DCB.
Sponsors
Leads: National Institute of Cardiology, Warsaw, Poland

This content was sourced from clinicaltrials.gov