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)

Fundación EPIC

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Drug Coated Balloon (DCB); Device: Drug Eluting Stent (DES)

Study type: Interventional

Funder types: Other

Identifiers

NCT06448637

EPIC37-DEBORA

Details and patient eligibility

About

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

Full 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

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Drug Coated Balloon (DCB)

Active Comparator group

Description:

Drug Coated Balloon (DCB)

Treatment:

Device: Drug Coated Balloon (DCB)

Drug Eluting Stent (DES)

Experimental group

Description:

Drug Eluting Stent (DES)

Treatment:

Device: Drug Eluting Stent (DES)