Drug-coated Balloon in de Novo Chronic Total Occlusions

Launched by NATIONAL INSTITUTE OF CARDIOLOGY, WARSAW, POLAND · Jul 28, 2023

Keywords

ClinConnect Summary

The CTO-DENOVO study is looking at a new treatment for patients with a specific type of heart problem called coronary artery disease, where a blood vessel in the heart is completely blocked (this is known as a chronic total occlusion or CTO). The researchers want to see how effective a special balloon coated with medication (called a drug-coated balloon or DCB) is when used alone to reopen these blocked arteries. They will track patients for six months to see if the treatment works and if there are any complications.

To be part of the study, patients need to be between 65 and 74 years old and have a new blockage in their heart arteries that can be successfully treated with this DCB technique. Patients who have had previous stents (tiny tubes placed in arteries) or those with different types of blockages won't be included. Those who participate can expect regular follow-up appointments to check how well the treatment is working using imaging tests that look inside the blood vessels. This study is currently recruiting participants, and it aims to improve treatment options for people with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site
• Exclusion Criteria:
• • de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site
• • in-stent CTO