Drug-Coated Balloon Coronary Angioplasty Versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion.

Launched by AMSTERDAM UMC, LOCATION VUMC · May 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for patients with a heart condition known as Chronic Total Occlusion (CTO), where a coronary artery is completely blocked. Researchers want to find out if using a special drug-coated balloon to treat the area right next to the blockage is just as effective as the standard method of placing a stent (a small mesh tube) in that area. Both treatments aim to improve blood flow and relieve symptoms for patients.

To participate in this study, you need to be at least 18 years old and have been diagnosed with CTO that requires treatment based on your doctor’s evaluation. You should also have had successful reopening of the blocked artery but still have some disease in the area adjacent to it. If you join the trial, you will be randomly assigned to receive either the drug-coated balloon treatment or a stent. The trial is currently looking for participants, and it's important to talk to your healthcare team if you think you might qualify or have any questions about joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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