NCT07839806Active, not recruiting
Drug-coated Balloons Versus Drug-eluting Stents for de Novo Small-vessel Coronary Artery Disease
Drug-Coated Balloons Versus Drug-Eluting Stents for De Novo Small-Vessel Coronary Artery Disease: A Prospective, Multicenter, Non-Randomized Observational Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels. The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 230 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- 3 Oct 2024
- Primary completion date
- 3 Dec 2026
- Lead sponsor
- National and Kapodistrian University of Athens
- Diseases
- Coronary artery disease
- NCT number
- NCT07839806
What you commit to
- Study type: Observational
- Planned participants: 230
- From 3 Oct 2024 to the primary completion date, 3 Dec 2026
- 1 site 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.
Other illness
- ST-elevation myocardial infarction requiring primary percutaneous coronary intervention.
- In-stent restenosis. Cardiogenic shock or hemodynamic instability at the time of the index procedure.
- Contraindication to antiplatelet therapy or to any component of the devices used.
- Life expectancy of less than 12 months because of a non-cardiovascular condition.
- Pregnancy. Inability to provide informed consent or complete the planned follow-up.
Who the study is looking for
- Age 18 years or older. Chronic coronary syndrome or non-ST-elevation acute coronary syndrome requiring percutaneous coronary intervention.
- De novo lesion in a native coronary artery. Reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Angiographic diameter stenosis greater than 70%. Successful lesion preparation, defined as residual stenosis of 30% or less, TIMI grade 3 flow, and absence of an NHLBI type C-F flow-limiting dissection.
- Treatment with a drug-coated balloon or a second-generation drug-eluting stent, selected at the discretion of the treating interventional cardiologist.
- Ability to provide informed consent and comply with clinical follow-up.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Department of Cardiology, Medical School of Athens, National and Kapodistrian University of Athens, General Hospital of Athens Ippokrateio, Athens, Greece Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.