Using drug-coated balloons to treat new coronary artery blockages
Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)
This study is testing if using drug-coated balloons can help people with new blockages in their coronary arteries feel better and have fewer problems after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland Academic / other |
| Locations | 35 sites (Graz and 34 other locations) |
| Trial ID | NCT05977842 on ClinicalTrials.gov |
What this trial studies
The CTO-DENOVO study is a multicenter registry that focuses on patients with new chronic total occlusions (CTO) of the coronary arteries who are treated using a drug-coated balloon (DCB) strategy. The study aims to evaluate the effectiveness of this approach by measuring target lesion failure at 6 months, along with late lumen loss and minimal lumen area through follow-up imaging. This observational study will gather data from multiple centers to assess outcomes and improve treatment strategies for coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are patients with de novo coronary CTO who can undergo successful recanalization using a DCB-only strategy.
Not a fit: Patients with in-stent CTO or those treated with drug-eluting stents (DES) will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of treatments for patients with chronic total occlusions in coronary arteries.
How similar studies have performed: While there have been studies on drug-coated balloons, this specific approach to treating de novo CTOs is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz and 34 other locations
- Graz University Heart Center — Graz, Austria (Recruiting)
- Klinik Ottakring — Vienna, Austria (Recruiting)
- Jolimont Hospital — Uccle, Belgium (Recruiting)
- Županijska bolnica Čakovec — Čakovec, Croatia (Recruiting)
- University Hospital Brno — Brno, Czechia (Recruiting)
- Liberec Regional Hospital — Liberec, Czechia (Recruiting)
- Kardiologické Centrum AGEL — Pardubice, Czechia (Recruiting)
- Lille University Hospital — Lille, France (Recruiting)
- Hospital zum Heiligen Geist — Kempen, Germany (Recruiting)
- University of Debrecen — Debrecen, Hungary (Recruiting)
- University of Szeged — Szeged, Hungary (Recruiting)
- Shamir Assaf Harofeh MC — Be'er Ya'aqov, Israel (Recruiting)
- Humanitas University — Milan, Italy (Recruiting)
- Villa Sofia Hospital — Palermo, Italy (Recruiting)
- Santissima Annunziata Hospital — Savigliano, Italy (Recruiting)
- Medical University of Bialystok — Białystok, Poland (Recruiting)
- American Heart of Poland — Bielsko-Biała, Poland (Recruiting)
- John Paul II Western Hospital — Grodzisk Mazowiecki, Poland (Recruiting)
- Jagiellonian University Medical College — Kraków, Poland (Recruiting)
- John Paul II Hospital — Kraków, Poland (Recruiting)
- 1st Military Hospital — Lublin, Poland (Recruiting)
- MSWiA Hospital — Lublin, Poland (Recruiting)
- Poznan University of Medical Sciences — Poznan, Poland (Recruiting)
- SP ZOZ Hospital — Puławy, Poland (Recruiting)
- MSWiA Hospital — Rzeszów, Poland (Recruiting)
- Bielanski Hospital — Warsaw, Poland (Recruiting)
- Military Institute of Medicine — Warsaw, Poland (Recruiting)
- National Institute of Cardiology — Warsaw, Poland (Recruiting)
- Dr Alfred Sokolowski Specialist Hospital — Wałbrzych, Poland (Recruiting)
- Wroclaw Medical University — Wrocław, Poland (Recruiting)
- Silesian Center for Heart Disease — Zabrze, Poland (Recruiting)
- MSWiA Hospital — Łódź, Poland (Recruiting)
- Heart Institute — Cluj-Napoca, Romania (Recruiting)
- Emergency Clinical County Hospital — Oradea, Romania (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Principal investigator: Maksymilian Opolski, MD — National Institute of Cardiology
- Study coordinator: Maksymilian Opolski, MD
- Email: mopolski@ikard.pl
- Phone: +48501444303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.