An observational study in Coronary Artery Disease, sponsored by National and Kapodistrian University of Athens. Active, not recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by National and Kapodistrian University of Athens · Observational
Among 75 studies in Coronary Artery Disease with a site in Greece — 12 open to participants now, 18 under way, 3 of them phase 3. Coronary Artery Disease · Greece.
Among the 75 studies in Coronary Artery Disease with a site in Greece, this one is the 18th largest by planned enrollment of the 24 observational ones that give a count, is one of 7 that started in 2024, is one of 24 observational ones, reaches primary completion later than 5 of the 17 other live ones, and was the 75th registered.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 230 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →12 of the 75 studies in Coronary Artery Disease with a site in Greece are open now.
A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →
Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →75 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 11 · Phase 4 13
First in 2003; this study’s year is marked. 7 started in 2024.
Median enrollment 120 across the 51 interventional studies, 727 across the 24 observational. Of the 46 that completed or were terminated, 7 (15%) have results posted.
16 of 75 have an industry lead sponsor. The 10 most frequent:
National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.
National and Kapodistrian University of Athens has 2 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
4 of the studies in Coronary Artery Disease with a site in Greece that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT07839806National and Kapodistrian University of AthensDrug-coated Balloons Versus Drug-eluting Stents for de Novo Small-vessel Coronary Artery Disease | 2026-12-03 |
| NCT05027984Centro per la Lotta Contro l'Infarto - Fondazione OnlusInterventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS | 2027-01-31 |
| NCT06839755Hellenic Society of CardiologyThe Positive Prognostic Value of Stress Echocardiography - AMPHIPOLIS STUDY | 2027-01-31 |
Among the 75 studies in Coronary Artery Disease with a site in Greece, from their registry updates:
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.
Small-vessel coronary artery disease remains a challenging setting for percutaneous coronary intervention because the limited vessel diameter increases the potential clinical impact of neointimal proliferation and restenosis. Second-generation drug-eluting stents represent an established treatment strategy, whereas drug-coated balloons deliver an antiproliferative agent without leaving a permanent metallic scaffold.
This is a prospective, multicenter, non-randomized observational study of consecutive patients undergoing percutaneous coronary intervention for de novo small-vessel coronary lesions. Lesion preparation and all procedural decisions will be performed according to contemporary clinical practice. Following adequate lesion preparation, the selection of a drug-coated balloon or a second-generation drug-eluting stent will be made by the treating interventional cardiologist on the basis of clinical, angiographic, and procedural considerations. The study protocol does not assign treatment and does not alter routine patient care.
Baseline demographic and clinical characteristics, angiographic findings, lesion characteristics, procedural details, device-related information, and in-hospital events will be recorded prospectively. Participants will undergo clinical follow-up for 12 months to document cardiovascular events, repeat coronary revascularization, and other relevant clinical outcomes. Outcomes will be compared between the drug-coated balloon and drug-eluting stent cohorts, taking into consideration the non-randomized nature of treatment selection and potential baseline differences between the groups.
Consecutive adult patients with chronic coronary syndrome or non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease at participating centers will be considered for inclusion. Eligible lesions will be located in native coronary arteries with a reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Patients will be included in the drug-coated balloon or second-generation drug-eluting stent cohort according to the treatment selected by the treating interventional cardiologist during routine clinical care. Treatment allocation will not be randomized or determined by the study protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 and comply with clinical follow-up.
Exclusion Criteria:
In-stent restenosis. Cardiogenic shock or hemodynamic instability at the time of the index procedure.
to antiplatelet therapy or to any component of the devices used.
of less than 12 months because of a non-cardiovascular condition.
Pregnancy. Inability to provide or complete the planned follow-up.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a drug-coated balloon after adequate lesion preparation. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care.
Device: Drug coated balloon
Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a second-generation drug-eluting stent. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care.
Device: Drug Eluting stent
Percutaneous coronary intervention performed using a drug-coated balloon following adequate lesion preparation. Balloon type, diameter, length, inflation pressure, and inflation duration are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice. Bailout stent implantation may be performed when clinically required, including in cases of significant residual stenosis, impaired coronary flow, or flow-limiting dissection.
Percutaneous coronary intervention performed using a second-generation drug-eluting stent following lesion preparation. Stent type, diameter, length, implantation pressure, and post-dilatation strategy are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice.
Major Adverse Cardiovascular Events
Number of participants experiencing at least one major adverse cardiovascular event, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or clinically driven target lesion revascularization.
Time frame: From the index procedure through 12 months
Cardiovascular Death
Time frame: Through 12 months
Nonfatal Myocardial Infarction
Time frame: Through 12 months
Target Vessel Revascularization
Time frame: Through 12 months
Procedural Success
Time frame: During the index procedure
Major Bleeding
Time frame: During hospitalization and through 12 months
Bailout Stent Implantation
Time frame: During the index procedure
Plan to share: No — Individual participant-level data are not currently planned to be shared because the study consent, institutional data-governance requirements, and applicable data-protection regulations do not provide for public or unrestricted sharing of participant-level clinical data. Aggregate study results may be reported in scientific publications and conference presentations.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.
Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 26 months is below that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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National and Kapodistrian University of Athens →