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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Drug Coated Balloon (DCB)
  • Drug Eluting Stent (DES)

Treatment groups

94 Participants
are divided into 2 treatment groups

Sponsors and collaborators