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

Last updated: April 18, 2025
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Chest Pain

Vascular Diseases

Treatment

Drug Eluting Stent (DES)

Drug Coated Balloon (DCB)

Clinical Study ID

NCT06448637
EPIC37-DEBORA
  • Ages > 18
  • All Genders

Study Summary

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Eligibility Criteria

Inclusion

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 segmentelevation or acute coronary syndrome with elevation ST segment in non-culpritlesions 48 hours after the event and;

  • Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significantno visible thrombus and;

  • Patients who have been informed of the characteristics of the study and haveprovided their written informed consent.

Exclusion

Exclusion Criteria:

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

  • Patients with any contraindication for the administration of acetylcholine (ACh) ornitroglycerin (NTG).

  • Patients with a history of coronary vasospasm or spontaneous dissection of thecoronary artery.

  • Patients with significant medical, surgical or psychiatric condition that wouldaffect the safety of the subject or influence the outcome of the study according tothe 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 ofthe coronary artery).

  • Patients with symptomatic congestive heart failure.

  • Patients with significant autoimmune inflammatory conditions and patients takingimmunomodulatory 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.

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Drug Eluting Stent (DES)
Phase:
Study Start date:
October 23, 2024
Estimated Completion Date:
May 01, 2027

Study Description

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Connect with a study center

  • Hospital Universitario de Cabueñes

    Gijón, 33394
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León, 24008
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, 270003
    Spain

    Active - Recruiting

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