Drug-Coated Coronary Balloons in Different Clinical Scenarios

NCT06915597 | Recruiting DMC

• 1 other identifier: DCB-DCS
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 5

Brief Summary

Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.

Conditions

Coronary Arterial Disease (CAD)

Keywords

drug coted balloons; coronary artery disease; chronic total occlusions; de novo lesions; small vessel disease

Outcome Measures

Primary Outcomes (1)

• Death, target lesion revascularization, target vessel revascularization, myocardial infarction

  Cardiac or noncardiac death events will be recorded during follow up. Forthermore, target vessel or lesion revascularization, myocardial infarction will be recorded according to the previously described criteria.

  12 months

Secondary Outcomes (1)

• Angina, target vessel revascularization, Procedural success and need for bailout stenting, Major bleeding (BARC ≥3)

  12 months

Study Arms (1)

Coronary artery disease

Patients with coronary artery disease who were treated with drug coated balloons will be included in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (≥18 years) with coronary artery disease who undergo percutaneous coronary intervention (PCI) in routine clinical practice in participating centers and are treated with a drug-coated balloon (DCB) for at least one target coronary lesion. The registry will include patients across a broad spectrum of clinical presentations, including stable coronary artery disease and acute coronary syndromes, and will encompass a wide range of lesion subsets such as de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Both prospectively and retrospectively enrolled patients will be included, reflecting real-world practice without additional diagnostic or therapeutic interventions beyond standard of care. The population will therefore represent an unselected, all-comer cohort treated with contemporary DCB-based strategies, allowing comprehensive evaluation of clinical and procedural outcomes.

You may qualify if:

• Age ≥18 years. Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) in whom a drug-coated balloon (DCB) is used as the intended treatment strategy for at least one target lesion.
• DCB use in any clinical presentation, including stable coronary artery disease and acute coronary syndromes.
• DCB treatment for different lesion subsets, including de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions.
• Successful lesion preparation allowing DCB angioplasty (residual stenosis ≤30% and absence of flow-limiting dissection before DCB inflation, according to operator judgment).
• Planned clinical follow-up.

You may not qualify if:

• Primary treatment strategy without the use of a drug-coated balloon (e.g., exclusive drug-eluting stent implantation without DCB).
• Cardiogenic shock at the time of index procedure. Life expectancy less than 1 year due to non-cardiac comorbidities. Contraindication to antiplatelet therapy. Known severe allergy to contrast media not amenable to premedication. Pregnancy. Inability to comply with clinical follow-up. Participation in another interventional clinical trial that could confound outcome assessment.

Sponsors & Collaborators

• Pamukkale University: collaborator
• Kutahya Health Sciences University: lead
• Marmara University: collaborator
• Trakya University: collaborator
• Kafkas University Health Research and Application Hospital: collaborator
• Selcuk University: collaborator
• Istanbul University - Cerrahpasa: collaborator
• Memorial Bahçelievler Hospital: collaborator
• Bezmialem Vakif University: collaborator
• Dicle University: collaborator
• Ordu University: collaborator
• Adana City Training and Research Hospital: collaborator

Study Sites (5)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

Bahcelievler Memorial Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Bezmialem Vakıf Universitesi

Istanbul, Turkey (Türkiye)

RECRUITING

Goztepe Medicalpark Hastanesi

Istanbul, Turkey (Türkiye)

RECRUITING

Kutahya City Hospital

Kütahya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Fatih Kahraman, Associate Professor

CONTACT

+905442764616; fatih.kahraman@ksbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 8, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5)