Status:
UNKNOWN
Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Chronic Total Occlusion of Coronary Artery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an investigator-initiated, randomized, multi-center, non-inferiority clinical trial. Patients with a Chronic Total Occlusion who are eligible for PCI will be randomized to additional Drug-Coat...
Detailed Description
Rationale: Chronic total coronary occlusions (CTOs) are documented in approximately 16-18% of diagnostic coronary angiograms. New developments such as retrograde approach and dissection re-entry techn...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Clinical indication for revascularization of the CTO as determined by the local heart team (based on symptoms, documented ischemia, and viability)
- Successful recanalization of the CTO with residual disease adjacent to the initial lesion
Exclusion
- Dissection affecting the flow (TIMI score\<3), significant recoil (\>30%) or coronary perforation after predilation
- Reference diameter of the vessel is \<2.5 mm or \>4.0 mm
- Bifurcation lesion requiring the stenting of the side branch
- Left main lesion
- Acute coronary syndrome
- Cardiogenic shock
- Severe kidney disease defined as an eGFR \< 30 ml/min
- Pregnancy
- Life expectancy \< 12 months
- Inability to give written consent
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04881812
Start Date
June 17 2021
End Date
March 31 2025
Last Update
September 22 2023
Active Locations (2)
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1
VUmc
Amsterdam, North Holland, Netherlands, 1081HV
2
Amsterdam Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ