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Drug-coated Balloon in de Novo Chronic Total Occlusions

NCT05977842 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 309

Last updated 2026-01-02

No results posted yet for this study

Summary

The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo coronary chronic total occlusions (CTO) undergoing successful CTO recanalization with the use of drug-coated balloon (DCB)-only strategy. The primary endpoint is target lesion failure at 6 months. The secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.

Conditions

Interventions

DEVICE

CTO PCI using DCB-only strategy

Successful CTO recanalization treated with DCB at the occlusion site

Sponsors & Collaborators

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Maksymilian Opolski, MD · National Institute of Cardiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-15
Primary Completion
2024-12-15
Completion
2025-01-01

Countries

  • Austria
  • Belgium
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05977842 on ClinicalTrials.gov