Comparing drug-coated balloons and drug-eluting stents for coronary artery disease

DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

This study is testing whether a special balloon or a stent works better to improve blood flow in people with coronary artery disease after eight months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación EPIC (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 7 sites (Barcelona and 6 other locations)
• Trial ID: NCT06448637 on ClinicalTrials.gov

What this trial studies

This study is a randomized, controlled, open-label, multicenter trial that evaluates the vasomotor function of patients with coronary artery disease eight months after treatment with either a drug-coated balloon (DCB) or a drug-eluting stent (DES) in large vessels measuring 3.5 mm or more. The study aims to determine the effectiveness of these two interventions in improving vascular function. Participants will be monitored for their response to treatment and any potential complications. The findings will contribute to understanding the best treatment options for patients with coronary artery disease.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic or acute coronary syndrome and de novo lesions in large coronary vessels.

Not a fit: Patients with contraindications to acetylcholine or nitroglycerin, or those with a history of coronary vasospasm, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with coronary artery disease, potentially improving their vascular health.

How similar studies have performed: Previous studies have shown varying success with drug-coated balloons and drug-eluting stents, but this specific comparative approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

Patients who meet all of the following conditions are included.

* Patients aged ≥ 18 years and;
* Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
* Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
* Patients who have been informed of the characteristics of the study and have provided their written informed consent.

Exclusion Criteria:

Patients who meet at least one of the following conditions are excluded:

* Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
* Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.
* Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.
* Patients who received a combination of DES and DCB in the same vessel
* Patients with glomerular filtration rate \<30 ml/min/ 1.73 m2
* Patients with body mass index \>35 (may affect the evaluation qualitative diameter of the coronary artery).
* Patients with symptomatic congestive heart failure.
* Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
* Patients with heart transplant.
* Patients with anemia (Hb \<12 g/dL in men and \<10 g/dL in women).
* Patients, women of childbearing age with a positive pregnancy test.
* Pregnant female patients.
* Patients included in other clinical trials with active follow-up.

Where this trial is running

Barcelona and 6 other locations

• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital Universitario de Cabueñes — Gijón, Spain (Recruiting)
• Hospital Universitario Juan Ramón Jiménez — Huelva, Spain (Recruiting)
• Hospital Universitario de Leon — León, Spain (Recruiting)
• Hospital Universitario Lucus Augusti — Lugo, Spain (Recruiting)
• Hospital Universitario Central de Asturias — Oviedo, Spain (Recruiting)
• Hospital Provincial de Pontevedra — Pontevedra, Spain (Recruiting)

Study contacts

• Study coordinator: IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD

Conditions Coronary Artery Disease; Drug-coated balloon; Vasomotor function