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

NCT06275386 | Recruiting DMC

• 1 other identifier: 2.31/II/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Occlusion of Coronary Artery; Coronary Artery Disease

Keywords

chronic total occlusion; percutaneous coronary intervention; drug-coated balloon

Outcome Measures

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.

  6-months

Secondary Outcomes (8)

• Angiographic outcomes assessed directly post-PCI

  immediately post-procedure (1 day)

• HD-IVUS outcomes assessed directly post-PCI

  immediately post-procedure (1 day)

• Physiologic outcomes assessed directly post-PCI

  immediately post-procedure (1 day)

• Angiographic outcomes at 6-months follow-up

  6-months

• HD-IVUS outcomes at 6-months follow-up

  6-months

Study Arms (1)

Drug-coated balloon

EXPERIMENTAL

Patients will undergo PCI of the native coronary CTO with a DCB.

Device: Paclitaxel Drug-coated balloon

Interventions

Paclitaxel Drug-coated balloon DEVICE

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

Drug-coated balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

National Institute of Cardiology

Warsaw, Masovian Voivodeship, 04-628, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Maksymilian Opolski

  National Institute of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maksymilian Opolski

CONTACT

0048(22)3434127; mopolski@ikard.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 23, 2024
• Study Start: March 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-10

Locations

PL (1)