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NCT06915597Recruiting

Drug-Coated Coronary Balloons in Different Clinical Scenarios

Procedural Success and Short- and Long-Term Outcomes of Drug-Coated Coronary Balloons Used in Different Clinical Scenarios

Source: ClinicalTrials.gov · Last updated 13 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
19 Mar 2025
Start date
31 May 2025
Primary completion date
31 May 2026
Lead sponsor
Kutahya Health Sciences University
NCT number
NCT06915597

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 31 May 2025 to the primary completion date, 31 May 2026
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Primary treatment strategy without the use of a drug-coated balloon (e.g., exclusive drug-eluting stent implantation without DCB).

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pamukkale University
Coordinator of this site? Confirm its status
DenizliTurkey (Türkiye)Recruiting
Goztepe Medicalpark Hastanesi
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
Bahçelievler Memorial Hospital
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
Bezmialem Vakıf Universitesi
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting
Kutahya City Hospital
Coordinator of this site? Confirm its status
KütahyaTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.