Drug-Coated Coronary Balloons in Different Clinical Scenarios

Recruiting now

Conditions studied: Coronary Arterial Disease (CAD)

In brief

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.

Key facts

Study ID

NCT06915597

Run by

Kutahya Health Sciences University

People needed

1500

Starts

2025-05-31

Expected to finish

2026-05-31

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• Availability of baseline clinical, angiographic, and procedural data. Ability to provide informed consent for prospective enrollment or availability of data according to local regulations for retrospective inclusion.
• 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.

Where it is running

• Pamukkale University — Denizli, Turkey (Türkiye) (enrolling)
• Bahcelievler Memorial Hospital — Istanbul, Turkey (Türkiye) (enrolling)
• Bezmialem Vakıf Universitesi — Istanbul, Turkey (Türkiye) (enrolling)
• Goztepe Medicalpark Hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
• Kutahya City Hospital — Kütahya, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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